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1. N-Methyl-D-Aspartate Antagonists and Steroids for the Prevention of Persisting Post-Surgical Pain After Thoracoscopic Surgeries: A Randomized Controlled, Factorial Design, International, Multicenter Pilot Trial

Author

Shanthanna H, Turan A, Vincent J, Saab R, Shargall Y, O'Hare T, Davis K, Fonguh S, Balasubramaniam K, Paul J, Gilron I, Kehlet H, Sessler DI, Bhandari M, Thabane L, and Devereaux PJ

Subjects
persisting pain, chronic pain, prevention, nmda antagonists, steroids, ketamine, Medicine (General), R5-920
Abstract

Harsha Shanthanna,1 Alparslan Turan,2 Jessica Vincent,3 Remie Saab,2 Yaron Shargall,4 Turlough O’Hare,1 Kimberly Davis,5 Sylvanus Fonguh,3 Kumar Balasubramaniam,3 James Paul,1 Ian Gilron,6 Henrik Kehlet,7 Daniel I Sessler,2 Mohit Bhandari,8 Lehana Thabane,9 PJ Devereaux9 1Department of Anesthesia, McMaster University, Hamilton, ON, Canada; 2Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA; 3Population Health Research Institute, Hamilton, ON, Canada; 4Department of Surgery, St Joseph’s Healthcare Hamilton, Hamilton, ON, Canada; 5Acute Pain Service, St. Joseph Healthcare Hamilton, Hamilton, ON, Canada; 6Departments of Anesthesiology and Perioperative Medicine, Biomedical and Molecular Sciences, Centre for Neuroscience Studies and School of Policy Studies, Queen’s University, Kingston, ON, Canada; 7Section of Surgical Pathophysiology, Rigshospitalet, Copenhagen, Denmark; 8Department of Surgery, McMaster University, Hamilton, ON, Canada; 9Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, CanadaCorrespondence: Harsha ShanthannaDepartment of Anesthesia, McMaster University, 1280 Main St. W., Hamilton, Ontario L8S 4K1, CanadaTel +1 905-525-9140 ext. 21737Fax +1 905-523-1224Email shanthh@mcmaster.caPurpose: We conducted a feasibility 2× 2 factorial trial comparing N-methyl-D-aspartate (NMDA) antagonists (intravenous ketamine and oral memantine) versus placebo and intravenous steroids versus placebo, in patients having elective video-assisted thoracic surgery lobectomies, at St. Joseph’s Hamilton, Canada, and Cleveland Clinic, Cleveland, USA. Our feasibility objectives were: 1) recruitment rate/week; 2) recruitment of ≥ 90% of eligible patients; and 3) > 90% follow-up. Secondary objectives were incidence and intensity of persistent post-surgical pain (PPSP) and other clinical and safety outcomes.Methods: Using computerized randomization, patients were allocated to one of four groups: NMDA active with steroid placebo; NMDA placebo with steroid active; both NMDA and steroid active; both NMDA and steroid placebo. Patients, health providers, and data analysts were blinded to allocation. Patients were followed for 3 months after randomization.Results: The trial was initiated in May 2017 at Hamilton and, after subsequent regulatory and ethics approval, in April 2018 at Cleveland. The trial had to be stopped after only 1 month of recruitment in Cleveland because the packaged study medications (memantine) expired and we were unable to procure the dosage required. Among 41 eligible patients, 27 (66%) were randomized. The recruitment rate/week was 0.63, 95% confidence interval (CI): 0.47– 0.79 in Hamilton; and 1, 95% CI: 0.83– 1.17 in Cleveland. Follow-up was complete for all 24 patients (100%) in Hamilton, and 3 of 4 patients in Cleveland. In total, only 4 patients (15%), and 2 patients (7%) had persistent pain at rest and with movement, respectively. There were no significant differences between groups for other outcomes.Conclusion: The trial had to be stopped prematurely due to non-availability of study medications. Trial feasibility objectives of recruiting 90% of eligible patients and recruiting at least one patient/week per site were not met. Consideration for protocol changes will be necessary for the full trial.Trial Registration: NCT02950233.Keywords: persisting pain, chronic pain, prevention, NMDA antagonists, steroids, ketamine

Published
2020

3. Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery : An International Randomized Controlled Trial.

Author

Marcucci, M, Painter, TW, Conen, D, Lomivorotov, V, Sessler, DI, Chan, MTV, Borges, FK, Leslie, K, Duceppe, E, Martínez-Zapata, MJ, Wang, CY, Xavier, D, Ofori, SN, Wang, MK, Efremov, S, Landoni, G, Kleinlugtenbelt, YV, Szczeklik, W, Schmartz, D, Garg, AX, Short, TG, Wittmann, M, Meyhoff, CS, Amir, M, Torres, D, Patel, A, Ruetzler, K, Parlow, JL, Tandon, V, Fleischmann, E, Polanczyk, CA, Lamy, A, Jayaram, R, Astrakov, SV, Wu, WKK, Cheong, CC, Ayad, S, Kirov, M, de Nadal, M, Likhvantsev, VV, Paniagua, P, Aguado, HJ, Maheshwari, K, Whitlock, RP, McGillion, MH, Vincent, J, Copland, I, Balasubramanian, K, Biccard, BM, Srinathan, S, Ismoilov, S, Pettit, S, Stillo, D, Kurz, A, Belley-Côté, EP, Spence, J, McIntyre, WF, Bangdiwala, SI, Guyatt, G, Yusuf, S, Devereaux, PJ, POISE-3 Trial Investigators and Study Groups, Marcucci, M, Painter, TW, Conen, D, Lomivorotov, V, Sessler, DI, Chan, MTV, Borges, FK, Leslie, K, Duceppe, E, Martínez-Zapata, MJ, Wang, CY, Xavier, D, Ofori, SN, Wang, MK, Efremov, S, Landoni, G, Kleinlugtenbelt, YV, Szczeklik, W, Schmartz, D, Garg, AX, Short, TG, Wittmann, M, Meyhoff, CS, Amir, M, Torres, D, Patel, A, Ruetzler, K, Parlow, JL, Tandon, V, Fleischmann, E, Polanczyk, CA, Lamy, A, Jayaram, R, Astrakov, SV, Wu, WKK, Cheong, CC, Ayad, S, Kirov, M, de Nadal, M, Likhvantsev, VV, Paniagua, P, Aguado, HJ, Maheshwari, K, Whitlock, RP, McGillion, MH, Vincent, J, Copland, I, Balasubramanian, K, Biccard, BM, Srinathan, S, Ismoilov, S, Pettit, S, Stillo, D, Kurz, A, Belley-Côté, EP, Spence, J, McIntyre, WF, Bangdiwala, SI, Guyatt, G, Yusuf, S, Devereaux, PJ, and POISE-3 Trial Investigators and Study Groups

Abstract

BACKGROUND: Among patients having noncardiac surgery, perioperative hemodynamic abnormalities are associated with vascular complications. Uncertainty remains about what intraoperative blood pressure to target and how to manage long-term antihypertensive medications perioperatively. OBJECTIVE: To compare the effects of a hypotension-avoidance and a hypertension-avoidance strategy on major vascular complications after noncardiac surgery. DESIGN: Partial factorial randomized trial of 2 perioperative blood pressure management strategies (reported here) and tranexamic acid versus placebo. (ClinicalTrials.gov: NCT03505723). SETTING: 110 hospitals in 22 countries. PATIENTS: 7490 patients having noncardiac surgery who were at risk for vascular complications and were receiving 1 or more long-term antihypertensive medications. INTERVENTION: In the hypotension-avoidance strategy group, the intraoperative mean arterial pressure target was 80 mm Hg or greater; before and for 2 days after surgery, renin-angiotensin-aldosterone system inhibitors were withheld and the other long-term antihypertensive medications were administered only for systolic blood pressures 130 mm Hg or greater, following an algorithm. In the hypertension-avoidance strategy group, the intraoperative mean arterial pressure target was 60 mm Hg or greater; all antihypertensive medications were continued before and after surgery. MEASUREMENTS: The primary outcome was a composite of vascular death and nonfatal myocardial injury after noncardiac surgery, stroke, and cardiac arrest at 30 days. Outcome adjudicators were masked to treatment assignment. RESULTS: The primary outcome occurred in 520 of 3742 patients (13.9%) in the hypotension-avoidance group and in 524 of 3748 patients (14.0%) in the hypertension-avoidance group (hazard ratio, 0.99 [95% CI, 0.88 to 1.12]; P = 0.92). Results were consistent for patients who used 1 or more than 1 antihypertensive medication in the long term. LIMITATION: Adherence to the as

Published
2023

5. Intraoperative dexamethasone does not increase the risk of postoperative wound infection: a propensity score-matched post hoc analysis of the ENIGMA-II trial (EnDEX)

Author

Corcoran, T., Kasza, J., Short, T. G., O’Loughlin, E., Chan, M. T. V., Leslie, K., Forbes, A., Paech, M., Myles, P., Myles, P, Wallace, S, Galagher, W, Farrington, C, Ditoro, A, Peyton, P, Baulch, S, Sidiropoulos, S, Bulach, R, Bryant, D, O’Loughlin, E, Mitteregger, V, Bolsin, S, Osborne, C, McRae, R, Backstrom, M, Leslie, K, Cotter, R, Paech, M, March, S, Silbert, B, Said, S, Halliwell, R, Cope, J, Fahlbusch, D, Crump, D, Thompson, G, Jefferies, A, McCulloch, T, Reeves, M, Buckley, N, Tidyl, T, Schricker, T, Lattermann, R, Iannuzzi, D, Beattie, S, Carroll, J, Jacka, M, Bryden, C, Badner, N, Chan, MTV, (ANZCA Trials Group member), Tsang, MWY, Cheng, BCP, Fong, ACM, Chu, LCY, Koo, EGY, Mohd, N, Ming, L E, Yin Wang, C, Campbell, D, McAllister, D, Walker, S, Olliff, S, Kennedy, R, Eldawlatly, A, Alzahrani, T, Chua, N, Haller, G, Pichon, I, Sneyd, R, McMillan, H, Parkinson, I, Rousseau, G, Brennan, A, Balaji, P, Cupitt, J, Nightingale, J, Kunst, G, Dickinson, M, Saran, T, Subramaniam, B, Banner-Godspeed, V, Sessler, DI, Liu, J, Kurz, A, Hesler, B, Fu, AY, Egan, C, Fiffick, AN, Hutcherson, MT, Turan, A, Naylor, A, Obal, D, and Cooke, E

Published
2017
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6. Covid-19 and Excess Mortality in Medicare Beneficiaries

Author

Gray J, Greenwald Sd, Clain D, Chamoun Ng, Sessler Di, Maheshwari K, and Paul J. Manberg

Subjects
Excess mortality, Chronic care, education.field_of_study, Coronavirus disease 2019 (COVID-19), business.industry, Incidence (epidemiology), Population, Medicare beneficiary, Disease, medicine, Social isolation, medicine.symptom, education, business, Demography
Abstract

We estimated excess mortality in Medicare recipients with probable and confirmed Covid-19 infections in the general community and amongst residents of long-term care (LTC) facilities. We considered 28,389,098 Medicare and dual-eligible recipients from one year before February 29, 2020 through September 30, 2020, with mortality followed through November 30th, 2020. Probable and confirmed Covid-19 diagnoses, presumably mostly symptomatic, were determined from ICD-10 codes. We developed a Risk Stratification Index (RSI) mortality model which was applied prospectively to establish baseline mortality risk. Excess deaths attributable to Covid-19 were estimated by comparing actual-to-expected deaths based on historical comparisons and in closely matched cohorts with and without Covid-19. 677,100 (2.4%) beneficiaries had confirmed Covid-19 and 2,917,604 (10.3%) had probable Covid-19. 472,329 confirmed cases were community living and 204,771 were in LTC. Mortality following a probable or confirmed diagnosis in the community increased from an expected incidence of about 4% to actual incidence of 7.5%. In long-term care facilities, the corresponding increase was from 20.3% to 24.6%. The absolute increase was therefore similar at 3-4% in the community and in LTC residents. The percentage increase was far greater in the community (89%) than among patients in chronic care facilities (21%) who had higher baseline risk. The LTC population without probable or confirmed Covid-19 diagnoses experienced 38,932 excess deaths (35%) compared to historical estimates. Limitations in access to Covid-19 testing and disease under-reporting in LTC patients probably were important factors, although social isolation and disruption in usual care presumably also contributed. Remarkably, there were 31,360 fewer deaths than expected in community dwellers without probable or confirmed Covid-19 diagnoses, representing a 6% reduction. Disruptions to the healthcare system and avoided medical care were thus apparently offset by other factors, representing overall benefit. The Covid-19 pandemic had marked effects on mortality, but the effects were highly context-dependent.

Published
2021

7. Design of Clinical Trials Evaluating Sedation in Critically Ill Adults Undergoing Mechanical Ventilation: Recommendations From Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research (SCEPTER) Recommendation III.

Author

Ward, DS, Absalom, AR, Aitken, LM, Balas, MC, Brown, DL, Burry, L, Colantuoni, E, Coursin, D, Devlin, JW, Dexter, F, Dworkin, RH, Egan, TD, Elliott, D, Egerod, I, Flood, P, Fraser, GL, Girard, TD, Gozal, D, Hopkins, RO, Kress, J, Maze, M, Needham, DM, Pandharipande, P, Riker, R, Sessler, DI, Shafer, SL, Shehabi, Y, Spies, C, Sun, LS, Tung, A, Urman, RD, Ward, DS, Absalom, AR, Aitken, LM, Balas, MC, Brown, DL, Burry, L, Colantuoni, E, Coursin, D, Devlin, JW, Dexter, F, Dworkin, RH, Egan, TD, Elliott, D, Egerod, I, Flood, P, Fraser, GL, Girard, TD, Gozal, D, Hopkins, RO, Kress, J, Maze, M, Needham, DM, Pandharipande, P, Riker, R, Sessler, DI, Shafer, SL, Shehabi, Y, Spies, C, Sun, LS, Tung, A, and Urman, RD

Abstract

OBJECTIVES: Clinical trials evaluating the safety and effectiveness of sedative medication use in critically ill adults undergoing mechanical ventilation differ considerably in their methodological approach. This heterogeneity impedes the ability to compare results across studies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations convened a meeting of multidisciplinary experts to develop recommendations for key methodologic elements of sedation trials in the ICU to help guide academic and industry clinical investigators. DESIGN: A 2-day in-person meeting was held in Washington, DC, on March 28–29, 2019, followed by a three-round, online modified Delphi consensus process. PARTICIPANTS: Thirty-six participants from academia, industry, and the Food and Drug Administration with expertise in relevant content areas, including two former ICU patients attended the in-person meeting, and the majority completed an online follow-up survey and participated in the modified Delphi process. MEASUREMENTS AND MAIN RESULTS: The final recommendations were iteratively refined based on the survey results, participants’ reactions to those results, summaries written by panel moderators, and a review of the meeting transcripts made from audio recordings. Fifteen recommendations were developed for study design and conduct, subject enrollment, outcomes, and measurement instruments. Consensus recommendations included obtaining input from ICU survivors and/or their families, ensuring adequate training for personnel using validated instruments for assessments of sedation, pain, and delirium in the ICU environment, and the need for methodological standardization. CONCLUSIONS: These recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommen

Published
2021

9. An open label pilot study of a dexmedetomidine-remifentanil-caudal anesthetic for infant lower abdominal/lower extremity surgery: The T REX pilot study

Author

Thomas, M, Szmuk, P, Andropoulos, D, McGowan, F, Brambrink, A, Lee, C, Lee, KJ, McCann, ME, Liu, Y, Saynhalath, R, Bong, CL, Anderson, BJ, Berde, C, De Graaff, JC, Disma, N, Kurth, D, Loepke, A, Orser, B, Sessler, DI, Skowno, JJ, von Ungern-Sternberg, BS, Vutskits, L, Davidson, A, Thomas, M, Szmuk, P, Andropoulos, D, McGowan, F, Brambrink, A, Lee, C, Lee, KJ, McCann, ME, Liu, Y, Saynhalath, R, Bong, CL, Anderson, BJ, Berde, C, De Graaff, JC, Disma, N, Kurth, D, Loepke, A, Orser, B, Sessler, DI, Skowno, JJ, von Ungern-Sternberg, BS, Vutskits, L, and Davidson, A

Abstract

BACKGROUND: Concern over potential neurotoxicity of anesthetics has led to growing interest in prospective clinical trials using potentially less toxic anesthetic regimens, especially for prolonged anesthesia in infants. Preclinical studies suggest that dexmedetomidine may have a reduced neurotoxic profile compared to other conventional anesthetic regimens; however, coadministration with either anesthetic drugs (eg, remifentanil) and/or regional blockade is required to achieve adequate anesthesia for surgery. The feasibility of this pharmacological approach is unknown. The aim of this study was to determine the feasibility of a remifentanil/dexmedetomidine/neuraxial block technique in infants scheduled for surgery lasting longer than 2 hours. METHODS: Sixty infants (age 1-12 months) were enrolled at seven centers over 18 months. A caudal local anesthetic block was placed after induction of anesthesia with sevoflurane. Next, an infusion of dexmedetomidine and remifentanil commenced, and the sevoflurane was discontinued. Three different protocols with escalating doses of dexmedetomidine and remifentanil were used. RESULTS: One infant was excluded due to a protocol violation and consent was withdrawn prior to anesthesia in another. The caudal block was unsuccessful in two infants. Of the 56 infants who completed the protocol, 45 (80%) had at least one episode of hypertension (mean arterial pressure >80 mm Hg) and/or movement that required adjusting the anesthesia regimen. In the majority of these cases, the remifentanil and/or dexmedetomidine doses were increased although six infants required rescue 0.3% sevoflurane and one required a propofol bolus. Ten infants had at least one episode of mild hypotension (mean arterial pressure 40-50 mm Hg) and four had at least one episode of moderate hypotension (mean arterial pressure <40 mm Hg). CONCLUSION: A dexmedetomidine/remifentanil neuraxial anesthetic regimen was effective in 87.5% of infants. These findings can be used as

Published
2019

10. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial

Author

Hemmes, S, Gama de Abreu, M, Severgnini, P, Hollmann, MW, Binnekade, JM, Wrigge, H, Canet, J, Hiesmayr, M, Schmid, W, Jaber, S, Hedenstierna, G, Putensen, C, Pelosi, P, Schultz, MJ, Sessler, DI, Lachmann, B, Kacmarek, RM, Slutsky, AS, De Baerdemaeker, L, De Hert, S, Heyse, B, Van Limmen, J, Mulier, JP, Velghe, D, Jamaer, L, Vandenbrande, J, Bugedo, G, Florez, J, Goranović, T, Mazul Sunko, B, Bluth, T, Güldner, A, Kiss, T, Koch, T, Spieth, PM, Uhlig, C, Yaqub, J, Bastin, B, Geib, J, Schaefer, MS, Weiss, M, Treschan, TA, Reske, AW, Simon, P, Brodhun, A, Ferner, M, Hartmann, E, Laufenberg Feldmann, R, Strys, L, De Robertis, E, Perilli, V, Proietti, R, Amantea, B, Caroleo, S, Tropea, F, Bacuzzi, A, Vanoni, M, Cinnella, G, Caggianelli, G, D'Antini, D, La Bella, D, Mollica, G, CORTEGIANI, Andrea, Montalto, F, Barberis, B, Celentano, C, Grio, M, Spagnolo, L, Gratarola, A, Molin, A, Pellerano, G, Pezzato, S, Rusca, R, Della Rocca, G, Bos, LD, Hemmes, SN, Brunelli, A, Marti, A, Cegarra, V, Merten, A, Moral, MV, Parera, A, Unzueta, MC, Sabaté, S, Sierra, P, Mayoral, JF, Prieto, M, Gil, MG, Marín, CM, Mills, GH, Bodger, P, Vidal Melo, MF, Sulemanji, D, Sprung, J., GIARRATANO, Antonino, RAINERI, Santi Maurizio, Hemmes, Sn, Gama de Abreu, M, Pelosi, P, Schultz, Mj, PROVE Network Investigators for the Clinical Trial Network of the European Society of, Anaesthesiology, DE ROBERTIS, Edoardo, AII - Amsterdam institute for Infection and Immunity, Anesthesiology, Intensive Care Medicine, ACS - Amsterdam Cardiovascular Sciences, Other Research, Hemmes, S, Severgnini, P, Hollmann, MW, Binnekade, JM, Wrigge, H, Canet, J, Hiesmayr, M, Schmid, W, Jaber, S, Hedenstierna, G, Putensen, C, Schultz, MJ, Sessler, DI, Lachmann, B, Kacmarek, RM, Slutsky, AS, De Baerdemaeker, L, De Hert, S, Heyse, B, Van Limmen, J, Mulier, JP, Velghe, D, Jamaer, L, Vandenbrande, J, Bugedo, G, Florez, J, Goranović, T, Mazul-Sunko, B, Bluth, T, Güldner, A, Kiss, T, Koch, T, Spieth, PM, Uhlig, C, Yaqub, J, Bastin, B, Geib, J, Schaefer, MS, Weiss, M, Treschan, TA, Reske, AW, Simon, P, Brodhun, A, Ferner, M, Hartmann, E, Laufenberg-Feldmann, R, Strys, L, De Robertis, E, Perilli, V, Proietti, R, Amantea, B, Caroleo, S, Tropea, F, Bacuzzi, A, Vanoni, M, Cinnella, G, Caggianelli, G, D'Antini, D, La Bella, D, Mollica, G, Cortegiani, A, Giarratano, A, Montalto, F, Raineri, SM, Barberis, B, Celentano, C, Grio, M, Spagnolo, L, Gratarola, A, Molin, A, Pellerano, G, Pezzato, S, Rusca, R, Della Rocca, G, Bos, LD, Hemmes, SN, Brunelli, A, Marti, A, Cegarra, V, Merten, A, Moral, MV, Parera, A, Unzueta, MC, Sabaté, S, Sierra, P, Mayoral, JF, Prieto, M, Gil, MG, Marín, CM, Mills, GH, Bodger, P, Vidal Melo, MF, Sulemanji, D, and Sprung, J

Subjects
Lung Diseases, Male, medicine.medical_specialty, medicine.medical_treatment, Settore MED/41 - Anestesiologia, Atelectasis, Anesthesia, General, Lung injury, Article, Positive-Pressure Respiration, abdominal surgery, PEEP, Postoperative Complications, Double-Blind Method, Risk Factors, Abdomen, Tidal Volume, medicine, Humans, General anaesthesia, PEEP, recruitment manoeuvres, abdominal surgery, Positive end-expiratory pressure, Tidal volume, Aged, Mechanical ventilation, business.industry, General Medicine, respiratory system, medicine.disease, Cardiac surgery, Surgery, Abdomen, Aged, Double-Blind Method, Humans, Lung Diseases, Positive-Pressure Respiration, Postoperative Complications, Risk Factors, Tidal Volume, Treatment Outcome, Treatment Outcome, Surgical Procedures, Operative, Anesthesia, Female, business, Abdominal surgery
Abstract

BACKGROUND: The role of positive end-expiratory pressure in mechanical ventilation during general anaesthesia for surgery remains uncertain. Levels of pressure higher than 0 cm H(2)O might protect against postoperative pulmonary complications but could also cause intraoperative circulatory depression and lung injury from overdistension. We tested the hypothesis that a high level of positive end-expiratory pressure with recruitment manoeuvres protects against postoperative pulmonary complications in patients at risk of complications who are receiving mechanical ventilation with low tidal volumes during general anaesthesia for open abdominal surgery. METHODS: In this randomised controlled trial at 30 centres in Europe and North and South America, we recruited 900 patients at risk for postoperative pulmonary complications who were planned for open abdominal surgery under general anaesthesia and ventilation at tidal volumes of 8 mL/kg. We randomly allocated patients to either a high level of positive end-expiratory pressure (12 cm H(2)O) with recruitment manoeuvres (higher PEEP group) or a low level of pressure (≤2 cm H(2)O) without recruitment manoeuvres (lower PEEP group). We used a centralised computer- generated randomisation system. Patients and outcome assessors were masked to the intervention. Primary endpoint was a composite of postoperative pulmonary complications by postoperative day 5. Analysis was by intention-to-treat. The study is registered at Controlled-Trials.com, number ISRCTN70332574. FINDINGS: From February, 2011, to January, 2013, 447 patients were randomly allocated to the higher PEEP group and 453 to the lower PEEP group. Six patients were excluded from the analysis, four because they withdrew consent and two for violation of inclusion criteria. Median levels of positive end-expiratory pressure were 12 cm H(2)O (IQR 12–12) in the higher PEEP group and 2 cm H(2)O (0–2) in the lower PEEP group. Postoperative pulmonary complications were reported in 174 (40%) of 445 patients in the higher PEEP group versus 172 (39%) of 449 patients in the lower PEEP group (relative risk 1·01; 95% CI 0·86–1·20; p=0·86). Compared with patients in the lower PEEP group, those in the higher PEEP group developed intraoperative hypotension and needed more vasoactive drugs. INTERPRETATION: A strategy with a high level of positive end-expiratory pressure and recruitment manoeuvres during open abdominal surgery does not protect against postoperative pulmonary complications. An intraoperative protective ventilation strategy should include a low tidal volume and low positive end-expiratory pressure, without recruitment manoeuvres. FUNDING: Academic Medical Center (Amsterdam, Netherlands), European Society of Anaesthesiology.

Published
2014

11. Implication of Major Adverse Postoperative Events and Myocardial Injury on Disability and Survival: A Planned Subanalysis of the ENIGMA-II Trial.

Author

Chan, MTV, Leslie, K, Myles, PS, O'Loughlin, E, Paech, MJ, Peyton, PJ, Halliwell, R, McMillan, H, Beattie, WS, Wijeysundera, DN, Sessler, DI, Wallace, S, Galagher, W, Farrington, C, Ditoro, A, Baulch, S, Sidiropoulos, S, Bulach, R, Bryant, D, Mitteregger, V, Bolsin, S, Osborne, C, McRae, R, Backstrom, M, Cotter, R, March, S, Said, S, Cope, J, Fahlbusch, D, Crump, D, Thompson, G, Jefferies, A, Reeves, M, Buckley, N, Tidy, T, Schricker, T, Lattermann, R, Iannuzzi, D, Carroll, J, Jacka, M, Bryden, C, Badner, N, Tsang, MWY, Cheng, BCP, Fong, ACM, Chu, LCY, Ko, EGY, Mohd, N, Ming, LE, Campbell, D, McAllister, D, Walker, S, Olliff, S, Kennedy, R, Eldawlatly, A, Alzahrani, T, Chua, N, Sneyd, R, Parkinson, I, Brennan, A, Balaji, P, NIghtingale, J, Kunst, G, Dickinson, M, Subramaniam, B, Banner-Godspeed, V, Liu, J, Kurz, A, Hesler, B, Fu, AY, Egan, C, Fiffick, AN, Hutcherson, MT, Turan, A, Naylor, A, Obal, D, Cooke, E, ANZCA Clinical Trials Network for the ENIGMA-II Investigators, X, Chan, MTV, Leslie, K, Myles, PS, O'Loughlin, E, Paech, MJ, Peyton, PJ, Halliwell, R, McMillan, H, Beattie, WS, Wijeysundera, DN, Sessler, DI, Wallace, S, Galagher, W, Farrington, C, Ditoro, A, Baulch, S, Sidiropoulos, S, Bulach, R, Bryant, D, Mitteregger, V, Bolsin, S, Osborne, C, McRae, R, Backstrom, M, Cotter, R, March, S, Said, S, Cope, J, Fahlbusch, D, Crump, D, Thompson, G, Jefferies, A, Reeves, M, Buckley, N, Tidy, T, Schricker, T, Lattermann, R, Iannuzzi, D, Carroll, J, Jacka, M, Bryden, C, Badner, N, Tsang, MWY, Cheng, BCP, Fong, ACM, Chu, LCY, Ko, EGY, Mohd, N, Ming, LE, Campbell, D, McAllister, D, Walker, S, Olliff, S, Kennedy, R, Eldawlatly, A, Alzahrani, T, Chua, N, Sneyd, R, Parkinson, I, Brennan, A, Balaji, P, NIghtingale, J, Kunst, G, Dickinson, M, Subramaniam, B, Banner-Godspeed, V, Liu, J, Kurz, A, Hesler, B, Fu, AY, Egan, C, Fiffick, AN, Hutcherson, MT, Turan, A, Naylor, A, Obal, D, Cooke, E, ANZCA Clinical Trials Network for the ENIGMA-II Investigators, and X

Abstract

BACKGROUND: Globally, >300 million patients have surgery annually, and ≤20% experience adverse postoperative events. We studied the impact of both cardiac and noncardiac adverse events on 1-year disability-free survival after noncardiac surgery. METHODS: We used the study cohort from the Evaluation of Nitrous oxide in Gas Mixture of Anesthesia (ENIGMA-II) trial, an international randomized trial of 6992 noncardiac surgical patients. All were ≥45 years of age and had moderate to high cardiac risk. The primary outcome was mortality within 1 postoperative year. We defined 4 separate types of postoperative adverse events. Major adverse cardiac events (MACEs) included myocardial infarction (MI), cardiac arrest, and myocardial revascularization with or without troponin elevation. MI was defined using the third Universal Definition and was blindly adjudicated. A second cohort consisted of patients with isolated troponin increases who did not meet the definition for MI. We also considered a cohort of patients who experienced major adverse postoperative events (MAPEs), including unplanned admission to intensive care, prolonged mechanical ventilation, wound infection, pulmonary embolism, and stroke. From this cohort, we identified a group without troponin elevation and another with troponin elevation that was not judged to be an MI. Multivariable Cox proportional hazard models for death at 1 year and assessments of proportionality of hazard functions were performed and expressed as an adjusted hazard ratio (aHR) and 95% confidence intervals (CIs). RESULTS: MACEs were observed in 469 patients, and another 754 patients had isolated troponin increases. MAPEs were observed in 631 patients. Compared with control patients, patients with a MACE were at increased risk of mortality (aHR, 3.36 [95% CI, 2.55-4.46]), similar to patients who suffered a MAPE without troponin elevation (n = 501) (aHR, 2.98 [95% CI, 2.26-3.92]). Patients who suffered a MAPE with troponin elevation but withou

Published
2018

12. The effect of anaesthetic technique during primary breast cancer surgery on neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and return to intended oncological therapy

Author

Eochagain, AN, Burns, D, Riedel, B, Sessler, DI, Buggy, DJ, Eochagain, AN, Burns, D, Riedel, B, Sessler, DI, and Buggy, DJ

Abstract

Inflammation and immunosuppression contribute to the pathogenesis of cancer. An increased neutrophil-lymphocyte ratio reflects these processes and is associated with adverse cancer outcomes. Whether anaesthetic technique for breast cancer surgery influences these factors, and potentially cancer recurrence, remains unknown. We conducted a secondary analysis in patients enrolled in an ongoing trial of anaesthetic technique on breast cancer recurrence. The primary hypothesis was that postoperative neutrophil-lymphocyte ratio is lower in patients allocated to receive propofol-paravertebral rather than inhalational agent-opioid anaesthesia for primary breast cancer surgery. Among 397 patients, 116 had differential white cell counts performed pre-operatively and postoperatively. Pre-operative neutrophil-lymphocyte ratio was similar in the propofol-paravertebral 2.3 (95%CI 1.8-2.8) and inhalational agent-opioid anaesthesia 2.2 (1.9-3.2) groups, p = 0.72. Postoperative neutrophil-lymphocyte ratio was lower (3.0 (2.4-4.2) vs. 4.0 (2.9-5.4), p = 0.001) in the propofol-paravertebral group. Propofol-paravertebral anaesthesia attenuated the postoperative increase in the neutrophil-lymphocyte ratio.

Published
2018

13. Pilot multi-centre randomised trial of the impact of pre-operative focused cardiac ultrasound on mortality and morbidity in patients having surgery for femoral neck fractures (ECHONOF-2 pilot)

Author

Canty, DJ, Heiberg, J, Yang, Y, Royse, AG, Margale, S, Nanjappa, N, Scott, D, Maier, A, Sessler, DI, Chuan, A, Palmer, A, Bucknill, A, French, C, Royse, CF, Canty, DJ, Heiberg, J, Yang, Y, Royse, AG, Margale, S, Nanjappa, N, Scott, D, Maier, A, Sessler, DI, Chuan, A, Palmer, A, Bucknill, A, French, C, and Royse, CF

Abstract

Hip fracture surgery is common, usually occurs in elderly patients who have multiple comorbidities, and is associated with high morbidity and mortality. Pre-operative focused cardiac ultrasound can alter diagnosis and management, but its impact on outcome remains uncertain. This pilot study assessed feasibility and group separation for a proposed large randomised clinical trial of the impact of pre-operative focused cardiac ultrasound on patient outcome after hip fracture surgery. Adult patients requiring hip fracture surgery in four teaching hospitals in Australia were randomly allocated to receive focused cardiac ultrasound before surgery or not. The primary composite outcome was any death, acute kidney injury, non-fatal myocardial infarction, cerebrovascular accident, pulmonary embolism or cardiopulmonary arrest within 30 days of surgery. Of the 175 patients screened, 100 were included as trial participants (screening:recruitment ratio 1.7:1), 49 in the ultrasound group and 51 as controls. There was one protocol failure among those recruited. The primary composite outcome occurred in seven of the ultrasound group patients and 12 of the control group patients (relative group separation 39%). Death, acute kidney injury and cerebrovascular accident were recorded, but no cases of myocardial infarction, pulmonary embolism or cardiopulmonary arrest ocurred. Focused cardiac ultrasound altered the management of 17 participants, suggesting an effect mechanism. This pilot study demonstrated that enrolment and the protocol are feasible, that the primary composite outcome is appropriate, and that there is a treatment effect favouring focused cardiac ultrasound - and therefore supports a large randomised clinical trial.

Published
2018

14. Validation of the cognitive recovery assessments with the Postoperative Quality of Recovery Scale in patients with low-baseline cognition

Author

Bowyer, AJ, Heiberg, J, Sessler, DI, Newman, S, Royse, AG, Royse, CF, Bowyer, AJ, Heiberg, J, Sessler, DI, Newman, S, Royse, AG, and Royse, CF

Abstract

Patients with pre-surgery cognitive impairment cannot currently be assessed for cognitive recovery after surgery using the Postoperative Quality of Recovery Scale (PostopQRS), as they would mathematically be scored as recovered. We aimed to validate a novel method to score cognitive recovery in patients with low-baseline cognition, using the number of low-score tests rather than their numerical values. Face validity was demonstrated in 86 participants in whom both the Postoperative Quality of Recovery Scale and an 11-item neuropsychological battery were performed. The Postoperative Quality of Recovery Scale agreed with neuropsychological categorisation of low vs. normal cognition 74% of the time, with all but five incorrectly coded participants deviating by only one neurocognitive test. Cognitive recovery over time was comparable for groups with differing baseline cognitive function, irrespective of whether the Postoperative Quality of Recovery Scale or neuropsychological methods were used. Discriminant validation was demonstrated in a post-hoc analysis of the steroids in cardiac surgery substudy by allocating groups to normal (n = 246) or low-baseline cognition (n = 231) stratified by cognitive recovery on day 1. Recovery was similar for participants with low and normal baseline cognition. Postoperative length of stay was longer in patients with failed cognitive recovery whether they had normal mean (SD) (10.4 (10.0) vs. 8.0 (5.9) days, p = 0.02) or low-baseline cognition (12.0 (11.1) vs. 8.2 (4.7) days, p < 0.01). Overall quality, as well as cognitive, emotive and physiological recovery was independent of baseline cognition. The modified scoring method for the Postoperative Quality of Recovery Scale cognitive domain demonstrates acceptable face and discriminant validity.

Published
2018

15. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort.

Author

Myles, PS, Peyton, PJ, Cyna, AM, Boney, O, Botti, M, Gan, TJ, Jensen, MP, Kehlet, H, Kurz, A, De Oliveira, GS Jr, Peyton, P, Sessler, DI, Tramèr, MR, Wu, CL, StEP–COMPAC Group, Myles, P, Grocott, M, Biccard, B, Blazeby, J, Chan, M, Diouf, E, Fleisher, L, Kalkman, C, Moonesinghe, R, Wijeysundera, D, Myles, PS, Peyton, PJ, Cyna, AM, Boney, O, Botti, M, Gan, TJ, Jensen, MP, Kehlet, H, Kurz, A, De Oliveira, GS Jr, Peyton, P, Sessler, DI, Tramèr, MR, Wu, CL, StEP–COMPAC Group, Myles, P, Grocott, M, Biccard, B, Blazeby, J, Chan, M, Diouf, E, Fleisher, L, Kalkman, C, Moonesinghe, R, and Wijeysundera, D

Abstract

BACKGROUND: Maximising patient comfort during and after surgery is a primary concern of anaesthetists and other perioperative clinicians, but objective measures of what constitutes patient comfort in the perioperative period remain poorly defined. The Standardised Endpoints in Perioperative Medicine initiative was established to derive a set of standardised endpoints for use in perioperative clinical trials. METHODS: We undertook a systematic review to identify measures of patient comfort used in the anaesthetic, surgical, and other perioperative literature. A multi-round Delphi consensus process that included up to 89 clinician researchers was then used to refine a recommended list of outcome measures. RESULTS: We identified 122 studies in a literature search, which were the basis for a preliminary list of 24 outcome measures and their definitions. The response rates for Delphi Rounds 1, 2, and 3 were 100% (n=22), 90% (n=79), and 100% (n=13), respectively. A final list of six defined endpoints was identified: pain intensity (at rest and during movement) at 24 h postoperatively, nausea and vomiting (0-6 h, 6-24 h, and overall), one of two quality-of-recovery (QoR) scales (QoR score or QoR-15), time to gastrointestinal recovery, time to mobilisation, and sleep quality. CONCLUSIONS: As standardised outcomes will support benchmarking and pooling (meta-analysis) of trials, one or more of these recommended endpoints should be considered for inclusion in clinical trials assessing patient comfort and pain after surgery

Published
2018

16. Association of postoperative high-sensitivity troponin levels with myocardial injury and 30-day mortality among patients undergoing noncardiac surgery

Author

Chan, MTV, Writing Committee for the VISION Study Investigators, Devereaux, PJ, Biccard BM, Sigamani, A, Xavier, D, Srinathan, SK, Walsh, M, Abraham, V, Pearse, R, Wang, CY, Sessler, DI, Kurz, A, Szczeklik, W, Berwanger, O, Villar, JC, Malaga, G, Garg, AX, Chow, CK, Ackland, G, Patel, A, Borges, FK, Belley-Cote, EP, Duceppe, E, Spence, J, Tandon, V, Williams, C, Sapsford, RJ, Polanczyk, CA, Tiboni, M, Alonso-Coello, P, Faruqui, A, Heels-Ansdell, D, Lamy, A, Whitlock, R, LeManach, Y, Roshanov, PS, McGillion, M, Kavsak, P, McQueen, MJ, Thabane, L, Rodseth, RN, Buse, GAL, Bhandari, M, Garutti, I, Jacka, MJ, Schünemann, HJ, Cortes, OL, Coriat, P, Dvirnik, N, Botto, F, Pettit, S, Jaffe, AS, Guyatt, GH, Chan, MTV, Writing Committee for the VISION Study Investigators, Devereaux, PJ, Biccard BM, Sigamani, A, Xavier, D, Srinathan, SK, Walsh, M, Abraham, V, Pearse, R, Wang, CY, Sessler, DI, Kurz, A, Szczeklik, W, Berwanger, O, Villar, JC, Malaga, G, Garg, AX, Chow, CK, Ackland, G, Patel, A, Borges, FK, Belley-Cote, EP, Duceppe, E, Spence, J, Tandon, V, Williams, C, Sapsford, RJ, Polanczyk, CA, Tiboni, M, Alonso-Coello, P, Faruqui, A, Heels-Ansdell, D, Lamy, A, Whitlock, R, LeManach, Y, Roshanov, PS, McGillion, M, Kavsak, P, McQueen, MJ, Thabane, L, Rodseth, RN, Buse, GAL, Bhandari, M, Garutti, I, Jacka, MJ, Schünemann, HJ, Cortes, OL, Coriat, P, Dvirnik, N, Botto, F, Pettit, S, Jaffe, AS, and Guyatt, GH

Abstract

IMPORTANCE: Little is known about the relationship between perioperative high-sensitivity troponin T (hsTnT) measurements and 30-day mortality and myocardial injury after noncardiac surgery (MINS). OBJECTIVE: To determine the association between perioperative hsTnT measurements and 30-day mortality and potential diagnostic criteria for MINS (ie, myocardial injury due to ischemia associated with 30-day mortality). DESIGN, SETTING, AND PARTICIPANTS: Prospective cohort study of patients aged 45 years or older who underwent inpatient noncardiac surgery and had a postoperative hsTnT measurement. Starting in October 2008, participants were recruited at 23 centers in 13 countries; follow-up finished in December 2013. EXPOSURES: Patients had hsTnT measurements 6 to 12 hours after surgery and daily for 3 days; 40.4% had a preoperative hsTnT measurement. MAIN OUTCOMES AND MEASURES: A modified Mazumdar approach (an iterative process) was used to determine if there were hsTnT thresholds associated with risk of death and had an adjusted hazard ratio (HR) of 3.0 or higher and a risk of 30-day mortality of 3% or higher. To determine potential diagnostic criteria for MINS, regression analyses ascertained if postoperative hsTnT elevations required an ischemic feature (eg, ischemic symptom or electrocardiography finding) to be associated with 30-day mortality. RESULTS: Among 21 842 participants, the mean age was 63.1 (SD, 10.7) years and 49.1% were female. Death within 30 days after surgery occurred in 266 patients (1.2%; 95% CI, 1.1%-1.4%). Multivariable analysis demonstrated that compared with the reference group (peak hsTnT <5 ng/L), peak postoperative hsTnT levels of 20 to less than 65 ng/L, 65 to less than 1000 ng/L, and 1000 ng/L or higher had 30-day mortality rates of 3.0% (123/4049; 95% CI, 2.6%-3.6%), 9.1% (102/1118; 95% CI, 7.6%-11.0%), and 29.6% (16/54; 95% CI, 19.1%-42.8%), with corresponding adjusted HRs of 23.63 (95% CI, 10.32-54.09), 70.34 (95% CI, 30.60-161.71), and 2

Published
2017

17. Aspirin in Patients Undergoing Noncardiac Surgery

Author

Devereaux, Pj, Mrkobrada, M, Sessler, Di, Leslie, K, Alonso Coello, P, Kurz, A, Villar, Jc, Sigamani, A, Biccard, Bm, Meyhoff, Cs, Parlow, Jl, Guyatt, G, Robinson, A, Garg, Ax, Rodseth, Rn, Botto, F, Lurati Buse, G, Xavier, D, Chan, Mt, Tiboni, M, Cook, D, Kumar, Pa, Forget, P, Malaga, G, Fleischmann, E, Amir, M, Eikelboom, J, Mizera, R, Torres, D, Wang, Cy, Vanhelder, T, Paniagua, P, Berwanger, O, Srinathan, S, Graham, M, Pasin, L, Le Manach, Y, Gao, P, Pogue, J, Whitlock, R, Lamy, A, Kearon, C, Baigent, C, Chow, C, Pettit, S, Chrolavicius, S, Yusuf, S, DeBeer J, POISE 2 I. n. v. e. s. t. i. g. a. t. o. r. s., Patel, A, Dechert, W, Jackson, P, Allard, R, Dumerton Shore, D, Mccourt, J, Jones, Pm, Lavi, R, Lavi, S, Moor, R, Dresser, Gk, Gros, Ml, Schumann, Vc, Baur, M, Macdonald, C, Wirzba, B, Regalado, O, Srinathan, Sk, Ong, Dd, Todd, A, Abbas, S, Beattie, Ws, Chan, Vw, Chin, Kj, Wijeysundera, Dn, Graham, Mm, Irwin, M, Jacka, M, El Beheiry, H, Mcmullen, Sm, Macdonald, P, Akhtar, Z, Ayad, S, Buttar, M, Deroee, A, Eshraghi, Y, Fergany, A, Finnigan, P, Fu, A, Grady, M, Helper, S, Hesler, B, Honar, H, Hutcherson, M, Krebs, V, Lee, J, Malik, M, Podolyak, A, Salmasi, V, Arora, H, Coombs, Rf, Martinelli, Sm, Bergese, Sd, Melibary, Sb, Uribe, Aa, Jordan, M, Miller, Sa, Cata, Jp, Nemergut, Ec, Candiotti, Ka, Memtsoudis, Sg, Mckay, Re, Montes, Fr, Parra, Ga, Rojas, Mf, Plata, R, Vásquez, Sm, Sarquis, T, Haider, Z, Jane, Nb, Lanjewar, Pp, Rahate, Pv, Mehra, Br, Premendaran, B, Abraham, V, George, P, Kumar, P, Gaikwad, Sb, Mohan, Nv, Sidhu, G, Alvarez, J, Gonzalez, R, Maestre, M, Popova, E, Urrutia, G, de Nadal, M, González Suárez, S, González Tallada, A, Plou, P, Mena, E, Riveira, C, del Valle, S, Tena, B, Lang, Sa, Ludbrook, Gl, Painter, Tw, Terblanche, Nc, Osborne, C, Mahood, Jr, Myles, Ps, Sivalingam, P, Riedel, B, Elhalawani, I, Drummond, L, Mugabi, A, Naidoo, P, Myburgh, Al, Porrill, Os, Diedericks, Bj, Turton, Ew, Bøgeskov, M, Dahl, Rm, Madsen, Mv, Søndergaard, Es, Bauer, Ne, Martinsen, Kr, Choi, Gy, Gin, T, Ng, Ss, Bidgoli, Sj, Van der Linden PJ, De Kock, M, Kabon, B, Luf, F, Radonic, M, Ishtiaq, O, Safdar, J, Acuna Villaorduna, A, Barrionuevo, P, Castaneda Guarderas, A, Caballero, Ja, Lau, Ve, Aphang Lam MR, Lembo, R, Gossetti, Bruno, Jara, X, Leon, P, Ong, Gs, Lee, Hs, Seeberger, Ee, Seeberger, Md, Alfonsi, P, Coriat, P, Piriou, V, Vizcaychipi, Mp, Rech, Rl, Bergo, Rr, Walker, S, Rodseth, R, Lemanach, Y, Díaz, R, Cortés, Ol, Wetterslev, J, Hoeft, A, Wittmann, M, Chan, M, Landoni, G, Conen, D, Balaji, P, Sovereign, T, Blake, L, Sephton, J, Serra, A, Agrippa, C, Lawrence, M, Biccard, B, Gluud, C, Karthikeyan, G, Auerbach, A, Beattie, S, Buckley, N, Douketis, J, Gerstein, H, Ghali, W, Hart, R, Hill, M, Mcalister, F, Mcauley, D, Miller, S, O'Donnell, M, Pais, P, Parlow, J, Schricker, T, Sessler, D, Simunovic, M, Teoh, K, Walsh, M, Wijeysundera, D, Yang, H, Alshalash, S, Bessissow, A, Duceppe, E, Khalid, Z, Khan, J, Lauw, M, Martinsen, K, Neary, J, Oczkowski, W, Papina, M, Seeberger, M, Tandon, V, Thomas, S, Friedman, L, Cheng, D, Johnstone, D, Lowenstein, E, Roberts, R., Devereaux, Pj, Mrkobrada, M, Sessler, Di, Leslie, K, Alonso Coello, P, Kurz, A, Villar, Jc, Sigamani, A, Biccard, Bm, Meyhoff, C, Parlow, Jl, Guyatt, G, Robinson, A, Garg, Ax, Rodseth, Rn, Botto, F, Lurati Buse, G, Xavier, D, Chan, Mt, Tiboni, M, Cook, D, Kumar, Pa, Forget, P, Malaga, G, Fleischmann, E, Amir M, Eikelboom J, Mizera, R, Torres, D, Wang, Cy, Vanhelder, T, Paniagua, P, Berwanger, O, Srinathan, S, Graham, M, Pasin, L, Le Manach, Y, Gao, P, Pogue, J, Whitlock, R, Lamy, A, Kearon, C, Baigent, C, Chow, C, Pettit, S, Chrolavicius, S, Yusuf, S, and Landoni, Giovanni

Subjects
Male, Myocardial Infarction, Kaplan-Meier Estimate, noncardiac surgery, postoperative period, law.invention, low drug dose, hazard ratio, Postoperative Complications, Randomized controlled trial, law, Myocardial infarction, Treatment Failure, Aspirin, Medicine (all), Hazard ratio, drug effect, article, risk assessment, General Medicine, Middle Aged, female, priority journal, Anesthesia, drug withdrawal, factorial design, Surgical Procedures, Operative, Platelet aggregation inhibitor, Female, medicine.drug, hospitalization, heart infarction, perioperative period, preoperative treatment, Postoperative Hemorrhage, Perioperative Care, length of stay, death, medicine, Humans, follow up, controlled study, human, clonidine, outcome assessment, Aged, treatment duration, Vascular disease, business.industry, Platelet Aggregation Inhibitor, patient care, acetylsalicylic acid, medicine.disease, bleeding, major clinical study, Confidence interval, purl.org/pe-repo/ocde/ford#3.02.00 [https], Clinical research, multicenter study, randomized controlled trial, placebo, Postoperative Complication, business, Platelet Aggregation Inhibitors
Abstract

BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not. METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P = 0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P = 0.04). The primary and secondary outcome results were similar in the two aspirin strata. CONCLUSIONS: Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.) Copyright © 2014 Massachusetts Medical Society.

Published
2014

18. Severe Nausea and Vomiting in the Evaluation of Nitrous Oxide in the Gas Mixture for Anesthesia II Trial

Author

Myles, PS, Myles PS, Chan MT, Kasza J, Paech MJ, Leslie K, Peyton PJ, Sessler DI, Haller G, Beattie WS, Osborne C, Sneyd JR, Forbes A, Myles, PS, Myles PS, Chan MT, Kasza J, Paech MJ, Leslie K, Peyton PJ, Sessler DI, Haller G, Beattie WS, Osborne C, Sneyd JR, and Forbes A

Abstract

BACKGROUND: The Evaluation of Nitrous oxide in the Gas Mixture for Anesthesia II trial randomly assigned 7,112 noncardiac surgery patients to a nitrous oxide or nitrous oxide-free anesthetic; severe postoperative nausea and vomiting (PONV) was a prespecified secondary end point. Thus, the authors evaluated the association between nitrous oxide, severe PONV, and effectiveness of PONV prophylaxis in this setting. METHODS: Univariate and multivariate analyses of patient, surgical, and other perioperative characteristics were used to identify the risk factors for severe PONV and to measure the impact of severe PONV on patient outcomes. RESULTS: Avoiding nitrous oxide reduced the risk of severe PONV (11 vs. 15%; risk ratio [RR], 0.74 [95% CI, 0.63 to 0.84]; P < 0.001), with a stronger effect in Asian patients (RR, 0.55 [95% CI, 0.43 to 0.69]; interaction P = 0.004) but lower effect in those who received PONV prophylaxis (RR, 0.89 [95% CI, 0.76 to 1.05]; P = 0.18). Gastrointestinal surgery was associated with an increased risk of severe PONV when compared with most other types of surgery (P < 0.001). Patients with severe PONV had lower quality of recovery scores (10.4 [95% CI, 10.2 to 10.7] vs. 13.1 [95% CI, 13.0 to 13.2], P < 0.0005); severe PONV was associated with postoperative fever (15 vs. 20%, P = 0.001). Patients with severe PONV had a longer hospital stay (adjusted hazard ratio, 1.14 [95% CI, 1.05 to 1.23], P = 0.002). CONCLUSIONS: The increased risk of PONV with nitrous oxide is near eliminated by antiemetic prophylaxis. Severe PONV, which is seen in more than 10% of patients, is associated with postoperative fever, poor quality of recovery, and prolonged hospitalization.

Published
2016

19. Clonidine in patients undergoing noncardiac surgery

Author

Devereaux, Pj, Sessler, Di, Leslie, K, Kurz, A, Mrkobrada, M, Alonso Coello, P, Villar, Jc, Sigamani, A, Biccard, Bm, Meyhoff, Cs, Parlow, Jl, Guyatt, G, Robinson, A, Garg, Ax, Rodseth, Rn, Botto, F, Lurati Buse, G, Xavier, D, Chan, Mt, Tiboni, M, Cook, D, Kumar, Pa, Forget, P, Malaga, G, Fleischmann, E, Amir, M, Eikelboom, J, Mizera, R, Torres, D, Wang, Cy, Vanhelder, T, Paniagua, P, Berwanger, O, Srinathan, S, Graham, M, Pasin, L, Le Manach, Y, Gao, P, Pogue, J, Whitlock, R, Lamy, A, Kearon, C, Chow, C, Pettit, S, Chrolavicius, S, Yusuf, S, Debeer, J, Patel, A, Dechert, W, Jackson, P, Allard, R, Dumerton Shore, D, Mccourt, J, Jones, Pm, Lavi, R, Lavi, S, Moor, R, Dresser, Gk, Gros, Ml, Schumann, Vc, Baur, M, Macdonald, C, Wirzba, B, Regalado, O, Srinathan, Sk, Ong, Dd, Todd, A, Abbas, S, Beattie, Ws, Chan, Vw, Chin, Kj, Wijeysundera, Dn, Graham, Mm, Irwin, M, Jacka, M, El Beheiry, H, Mcmullen, Sm, Macdonald, P, Akhtar, Z, Ayad, S, Buttar, M, Deroee, A, Eshraghi, Y, Fergany, A, Finnigan, P, Fu, A, Grady, M, Helper, S, Hesler, B, Honar, H, Hutcherson, M, Krebs, V, Lee, J, Malik, M, Podolyak, A, Salmasi, V, Arora, H, Coombs, Rf, Martinelli, Sm, Bergese, Sd, Melibary, Sb, Uribe, Aa, Jordan, M, Miller, Sa, Cata, Jp, Nemergut, Ec, Candiotti, Ka, Memtsoudis, Sg, Mckay, Re, Montes, Fr, Parra, Ga, Rojas, Mf, Plata, R, Vásquez, Sm, Sarquis, T, Haider, Z, Jane, Nb, Lanjewar, Pp, Rahate, Pv, Mehra, Br, Premendaran, B, Abraham, V, George, P, Kumar, P, Gaikwad, Sb, Mohan, Nv, Sidhu, G, Alvarez, J, Gonzalez, R, Maestre, M, Popova, E, Urrutia, G, de Nadal, M, González Suárez, S, González Tallada, A, Plou, P, Mena, E, Riveira, C, del Valle, S, Tena, B, Lang, Sa, Ludbrook, Gl, Painter, Tw, Terblanche, Nc, Osborne, C, Mahood, Jr, Myles, Ps, Sivalingam, P, Riedel, B, Elhalawani, I, Drummond, L, Mugabi, A, Naidoo, P, Myburgh, Al, Porrill, Os, Diedericks, Bj, Turton, Ew, Bøgeskov, M, Dahl, Rm, Madsen, Mv, Søndergaard, Es, Bauer, Ne, Martinsen, Kr, Choi, Gy, Gin, T, Ng, Ss, Bidgoli, Sj, Van der Linden PJ, De Kock, M, Kabon, B, Luf, F, Radonic, M, Ishtiaq, O, Safdar, J, Acuna Villaorduna, A, Barrionuevo, P, Castaneda Guarderas, A, Caballero, Ja, Lau, Ve, Aphang Lam MR, Lembo, R, Gossetti, Bruno, Jara, X, Leon, P, Ong, G, Lee, Hs, Seeberger, Ee, Seeberger, Md, Alfonsi, P, Coriat, P, Piriou, V, Vizcaychipi, Mp, Rech, Rl, Bergo, Rr, Walker, S, Rodseth, R, Lemanach, Y, Díaz, R, Cortés, Ol, Wetterslev, J, Hoeft, A, Wittmann, M, Chan, M, Landoni, G, Conen, D, Balaji, P, Sovereign, T, Blake, L, Sephton, J, Serra, A, Agrippa, C, Lawrence, M, Biccard, B, Gluud, C, Baigent, C, Karthikeyan, G, Auerbach, A, Beattie, S, Buckley, N, Douketis, J, Gerstein, H, Ghali, W, Hart, R, Hill, M, Mcalister, F, Mcauley, D, Miller, S, O'Donnell, M, Pais, P, Parlow, J, Schricker, T, Sessler, D, Simunovic, M, Teoh, K, Walsh, M, Wijeysundera, D, Yang, H, Alshalash, S, Bessissow, A, Duceppe, E, Khalid, Z, Khan, J, Lauw, M, Martinsen, K, Neary, J, Oczkowski, W, Papina, M, Seeberger, M, Tandon, V, Thomas, S, Friedman, L, Cheng, D, Johnstone, D, Lowenstein, E, and Roberts, R.

Subjects
Male, hypotension, drug safety, Heart disease, Myocardial Infarction, Kaplan-Meier Estimate, high risk patient, noncardiac surgery, surgery, low drug dose, hazard ratio, Postoperative Complications, dose response, Adrenergic alpha-2 Receptor Agonists, Myocardial infarction, Treatment Failure, risk reduction, Aspirin, Hazard ratio, drug effect, article, risk assessment, General Medicine, Middle Aged, Clonidine, aged, female, priority journal, Anesthesia, factorial design, Surgical Procedures, Operative, Female, Hypotension, medicine.drug, medicine.medical_specialty, heart infarction, perioperative period, preoperative treatment, Placebo, bradycardia, Perioperative Care, length of stay, death, medicine, Humans, controlled study, human, Aged, treatment duration, business.industry, Perioperative, Vascular surgery, acetylsalicylic acid, medicine.disease, major clinical study, purl.org/pe-repo/ocde/ford#3.02.00 [https], drug efficacy, multicenter study, randomized controlled trial, incidence, treatment outcome, placebo, business, heart arrest
Abstract

Background: Marked activation of the sympathetic nervous system occurs during and after noncardiac surgery. Low-dose clonidine, which blunts central sympathetic outflow, may prevent perioperative myocardial infarction and death without inducing hemodynamic instability. Methods: We performed a blinded, randomized trial with a 2-by-2 factorial design to allow separate evaluation of low-dose clonidine versus placebo and low-dose aspirin versus placebo in patients with, or at risk for, atherosclerotic disease who were undergoing noncardiac surgery. A total of 10,010 patients at 135 centers in 23 countries were enrolled. For the comparison of clonidine with placebo, patients were randomly assigned to receive clonidine (0.2 mg per day) or placebo just before surgery, with the study drug continued until 72 hours after surgery. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. Results: Clonidine, as compared with placebo, did not reduce the number of primary-outcome events (367 and 339, respectively; hazard ratio with clonidine, 1.08; 95% confidence interval [CI], 0.93 to 1.26; P=0.29). Myocardial infarction occurred in 329 patients (6.6%) assigned to clonidine and in 295 patients (5.9%) assigned to placebo (hazard ratio, 1.11; 95% CI, 0.95 to 1.30; P=0.18). Significantly more patients in the clonidine group than in the placebo group had clinically important hypotension (2385 patients [47.6%] vs. 1854 patients [37.1%]; hazard ratio 1.32; 95% CI, 1.24 to 1.40; P

Published
2014

20. ESICM LIVES 2016: part two : Milan, Italy. 1-5 October 2016

Author

Sivakumar, S, Taccone, FS, Desai, KA, Lazaridis, C, Skarzynski, M, Sekhon, M, Henderson, W, Griesdale, D, Chapple, L, Deane, A, Williams, L, Ilia, S, Henderson, A, Hugill, K, Howard, P, Roy, A, Bonner, S, Monteiro, E, Baudouin, S, Ramírez, CS, Escalada, SH, Banaszewski, M, Sertedaki, A, Kaymak, Ç, Viera, MA, Santana, MC, Balcázar, LC, Monroy, NS, Campelo, FA, Vázquez, CF, Santana, PS, Cerejo, A, Santana, SR, Charmadari, E, Carteron, L, Kovach, L, Patet, C, Quintard, H, Solari, D, Bouzat, P, Oddo, M, Wollersheim, T, Malleike, J, Haas, K, Stratakis, CA, Rocha, AP, Carbon, N, Şencan, I, Schneider, J, Birchmeier, C, Fielitz, J, Spuler, S, Weber-Carstens, S, Enseñat, L, Pérez-Madrigal, A, Briassouli, E, Saludes, P, Proença, L, Elsayed, AA, Meço, B, Gruartmoner, G, Espinal, C, Mesquida, J, Huber, W, Eckmann, M, Elkmann, F, Goukos, D, Gruber, A, Lahmer, T, Mayr, U, Herner, A, Özçelik, M, Abougabal, AM, Schellnegger, R, Schmid, RM, Ayoub, W, Psarra, K, Samy, W, Esmat, A, Battah, A, Mukhtar, S, Mongkolpun, W, Ünal, N, Cortés, DO, Beshey, BN, Cordeiro, CP, Vincent, JL, Leite, MA, Creteur, J, Funcke, S, Groesdonk, H, Saugel, B, Wagenpfeil, G, Wagenpfeil, S, Reuter, DA, Fernandez, MM, Alzahaby, KM, Botoula, E, Fernandez, R, Magret, M, González-Castro, A, Bouza, MT, Ibañez, M, García, C, Balerdi, B, Jenni-Moser, B, Mas, A, Arauzo, V, Tsagarakis, S, Añón, JM, Pozzebon, S, Ruiz, F, Ferreres, J, Tomás, R, Alabert, M, Tizón, AI, Altaba, S, Jeitziner, MM, Llamas, N, Haroon, BA, Edul, VS, Goligher, EC, Fan, E, Herridge, M, Ortiz, AB, Vorona, S, Sklar, M, Dres, M, Rittayamai, N, Lanys, A, Schreiber, J, Mageira, E, Urrea, C, Tomlinson, G, Reid, WD, Rubenfeld, GD, Kavanagh, BP, Cristallini, S, Brochard, LJ, Ferguson, ND, Neto, AS, De Abreu, MG, Routsi, C, Imiela, J, Galassi, MS, Pelosi, P, Schultz, MJ, PRoVENT investigators and the PROVE Network, Guérin, C, Papazian, L, Reignier, J, Lheureux, O, Ayzac, L, Nanas, S, Loundou, A, Forel, JM, Sales, FL, Rolland-Debord, C, Bureau, C, Poitou, T, Clavel, M, Perbet, S, Terzi, N, Kouatchet, A, Briassoulis, G, Brasseur, A, Similowski, T, Demoule, A, De Moraes, KC, Hunfeld, N, Trogrlic, Z, Ladage, S, Osse, RJ, Koch, B, Rietdijk, W, Boscolo, A, Devlin, J, Van der Jagt, M, Picetti, E, Batista, CL, Ceccarelli, P, Mensi, F, Malchiodi, L, Risolo, S, Rossi, I, Bertini, D, Antonini, MV, Servadei, F, Caspani, ML, Roquilly, A, Júnior, JA, Lasocki, S, Seguin, P, Geeraerts, T, Perrigault, PF, Campello, E, Dahyot-Fizelier, C, Paugam-Burtz, C, Cook, F, Cinotti, R, Dit Latte, DD, Mahe, PJ, Marcari, TB, Fortuit, C, Feuillet, F, Lucchetta, V, Asehnoune, K, Marzorati, C, Spina, S, Scaravilli, V, Vargiolu, A, Riva, M, Giussani, C, Lobato, R, Sganzerla, E, Hravnak, M, Osaku, EF, Citerio, G, Barbadillo, S, De Molina, FJ, Álvarez-Lerma, F, Rodríguez, A, SEMICYUC/GETGAG Working Group, Zakharkina, T, Martin-Loeches, I, Castro, CS, Matamoros, S, Fuhrmann, V, Piasentini, E, Povoa, P, Yousef, K, Torres, A, Kastelijn, J, Hofstra, JJ, De Jong, M, Schultz, M, Sterk, P, Artigas, A, De Souza, LM, Aktepe, O, Bos, LJ, Moreau, AS, Chang, Y, Salluh, J, Rodriguez, A, Nseir, S, TAVeM study group, De Jong, E, Fildisis, G, Rodrigues, FF, Van Oers, JA, Beishuizen, A, Girbes, AR, Nijsten, MW, Crago, E, De Lange, DW, Bonvicini, D, Labate, D, Benacchio, L, Radu, CM, Olivieri, A, Stepinska, J, Wruck, ML, Pizzirani, E, Lopez-Delgado, JC, Gonzalez-Romero, M, Fuentes-Mila, V, Berbel-Franco, D, Friedlander, RM, Romera-Peregrina, I, Manesso, L, Martinez-Pascual, A, Perez-Sanchez, J, Abellan-Lencina, R, Correa, NG, Ávila-Espinoza, RE, Moreno-Gonzalez, G, Sbraga, F, Griffiths, S, Grocott, MP, Creagh-Brown, B, Simioni, P, Abdelmonem, SA, POPC-CB investigators, Doyle, J, Wilkerson, P, Pelegrini, AM, Soon, Y, Huddart, S, Dickinson, M, Riga, A, Zuleika, A, Ori, C, Miyamoto, K, Kawazoe, Y, Tahon, SA, Morimoto, T, Yamamoto, T, Eid, RA, Fuke, A, Hashimoto, A, Koami, H, Beppu, S, Su, H, Katayama, Y, Ito, M, Ohta, Y, Yamamura, H, Helmy, TA, DESIRE (DExmedetomidine for 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K, Rutter, K, Tsolaki, B, Funk, GC, Póvoa, P, Ramos, AJ, Schneeweiss, B, Sabetian, G, Pooresmaeel, F, Zand, F, Ghaffaripour, S, Farbod, A, Tabei, H, Taheri, L, TAVeM study Group, Karadodas, B, Reina, Á, Anandanadesan, R, Metaxa, V, Teixeira, C, Pereira, SM, Hernández-Marrero, P, Carvalho, AS, Beckmann, M, Hartog, CS, Varis, E, Raadts, A, López, NP, Zakynthinos, E, Robertsen, A, Førde, R, Skaga, NO, Helseth, E, Honeybul, S, Ho, K, Vazquez, AR, Lopez, PM, Gonzalez, MN, Ortega, PN, Pérez, MA, Sola, EC, Garcia, IP, Spasova, T, De la Torre-Prados, MV, Kopecky, O, Rusinova, K, Pettilä, V, Waldauf, P, Cepeplikova, Z, Balik, M, Ordoñez, PF, Apolo, DX, Almudevar, PM, Martin, AD, Muñoz, JJ, Poukkanen, M, Castañeda, DP, Villamizar, PR, Ramos, JV, Pérez, LP, Lucendo, AP, Villén, LM, Ejarque, MC, Estella, A, Camps, VL, Neitzke, NM, Encinares, VS, Martín, MC, Masnou, N, Bioethics work group of SEMICYUC, Barbosa, S, Varela, A, Palma, I, López, FM, Cristina, L, Nunes, E, Jacob, S, Pereira, I, Campello, G, Ibañez, MP, Granja, C, Pande, R, Pandey, M, Varghese, S, Chanu, M, García, IP, Van Dam, MJ, Schildhauer, C, Karlsson, S, Ter Braak, EW, Gracia, M, Viciana, R, Montero, JG, Recuerda, M, Fontaiña, LP, Tharmalingam, B, Kovari, F, Zöllner, C, Rose, L, Mcginlay, M, Amin, R, Burns, K, Connolly, B, Hart, N, Labrador, G, Jouvet, P, Katz, S, Leasa, D, Takala, J, Izurieta, JR, Mawdsley, C, Mcauley, D, Blackwood, B, Denham, S, Worrall, R, Arshad, M, Cangueiro, TC, Isherwood, P, Wilkman, E, Khadjibaev, A, Guerrero, JJ, Sabirov, D, Rosstalnaya, A, Parpibaev, F, Sharipova, V, Guzman, CI, FINNAKI Study Group, Poulose, V, Renal Transplantation HUVR, Lundberg, OH, Koh, J, Calvert, S, Cha, YS, Lee, SJ, Tyagi, N, Rajput, RK, Birri, PN, Taneja, S, Singh, VK, Sharma, SC, Mittal, S, Quint, M, Kam, JW, Rao, BK, Ayachi, J, Fraj, N, Romdhani, S, Bergenzaun, L, Khedher, A, Meddeb, K, Sma, N, Azouzi, A, Bouneb, R, Giribet, A, Adeniji, K, Chouchene, I, Yeter, H, El Ghardallou, M, Rydén, J, 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Laisne, L, Rabbat, A, Lebert, C, Perez, P, Suberviola, B, Chaize, M, Renault, A, Meert, AP, Hamidfar, R, Jourdain, M, Rodríguez-Mejías, C, Lanziotti, VS, Darmon, M, Schlemmer, B, Chevret, S, Lemiale, V, Azoulay, E, Rowland, MJ, Riera, J, Benoit, D, Martins-Branco, D, Sousa, M, Wangensteen, R, Marum, S, Bouw, MJ, Galstyan, G, Makarova, P, Parovichnikova, E, Kuzmina, L, Troitskaya, V, Rellan, L, Drize, N, Zaponi, RS, Gemdzhian, E, Jamaati, HR, Savchenko, V, Chao, HC, Kılıc, E, Demiriz, B, Uygur, ML, Sürücü, M, Cınar, K, Yıldırım, AE, Pulcheri, L, Sanchez, M, Kiss, K, Masjedi, M, Köves, B, Csernus, V, Molnár, Z, Ntantana, A, Matamis, D, Savvidou, S, Giannakou, M, Ribeiro, MO, Gouva, M, Nakos, G, Robles, JC, Koulouras, V, Gaffney, S, Docking, R, Judge, C, Drew, T, Barbosa, AP, Misran, H, Munshi, R, McGovern, L, Coyle, M, Hashemian, SM, Lopez, E, Dunne, L, Deasy, E, Lavin, P, Fahy, A, Antoniades, CA, Ramos, A, Darcy, DM, Donnelly, M, Ismail, NH, Hall, T, Wykes, K, Jack, J, Vicente, R, Ngu, WC, Morgan, P, E Silva, JR, Ruiz-Ramos, J, Ramirez, P, Gordon, M, Villarreal, E, Frasquet, J, Poveda-Andrés, JL, Abbasi, G, Castellanos, A, Ijssennagger, CE, Miñambres, E, Soares, M, Ten Hoorn, S, Van Wijk, A, Van den Broek, JM, Tuinman, PR, Elmenshawy, AM, Hammond, BD, Gibbon, G, Khaloo, V, Belcham, T, Burton, K, Salluh, JI, Taniguchi, LU, Santibañez, M, Ramos, FJ, Momma, AK, Martins-Filho, AP, Bartocci, JJ, Lopes, MF, Sad, MH, Tabei, SH, Rodrigues, CM, Pires, EM, Vieira, JM, Le Guen, M, Murbach, LD, Barreto, J, Duarte, ST, Taba, S, Kolaros, AA, Miglioranza, D, Gund, DP, Lordani, CF, Ogasawara, SM, Moore, J, Jorge, AC, Duarte, PA, Capuzzo, M, Marqués, MG, Kafilzadeh, A, Corte, FD, Terranova, S, Scaramuzzo, G, Fogagnolo, A, Bertacchini, S, Bellonzi, A, Garry, P, Mason, N, Ragazzi, R, Moreno, AP, Bakhodaei, HH, Cruz, C, Nunes, A, Pereira, FS, Aragão, I, Cardoso, AF, Santos, C, Malheiro, MJ, Castro, H, Abentroth, LR, Windpassinger, M, Cardoso, T, Diaz, JA, Paratz, J, Kenardy, J, Comans, 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Perchiazzi, G, Borges, JB, Queen Square Neuroanaesthesia and Neurocritical Care Resreach Group, Bayat, S, Porra, L, Mirek, S, Broche, L, Hedenstierna, G, Larsson, A, Kennedy, RM, Roneus, A, Segelsjö, M, Vestito, MC, Zeman, PM, Gremo, E, Nyberg, A, Castegren, M, Pikwer, A, Sharma, S, Monfort, B, Yoshida, T, Engelberts, D, Otulakowski, G, Katira, B, Post, M, Brochard, L, Amato, MB, Stazi, E, PLUG Working group, Koch, N, Hoellthaler, J, Mair, S, Phillip, V, Van Ewijk, CE, Beitz, A, González, LR, Roig, AL, Baladrón, V, Yugi, G, Calvo, FJ, Padilla, D, Villarejo, P, Villazala, R, Yuste, AS, Bejarano, N, Steenstra, RJ, Jacobs, GE, Banierink, H, Hof, J, Martika, A, Hoekstra, M, Sterz, F, Horvatits, K, Herkner, H, Magnoni, S, Marando, M, Faivre, V, Pifferi, S, Conte, V, Ortolano, F, Alonso, DC, Carbonara, M, Bertani, G, Scola, E, Cadioli, M, Triulzi, F, Colombo, A, Nevière, R, Stocchetti, N, Fatania, G, Hernández-Sánchez, N, Rotzel, HB, Lázaro, AS, Prada, DA, Guimillo, MR, Piqueras, CS, Guia, JR, Simon, MG, Thiébaut, PA, Arizmendi, AM, Carratalá, A, Sánchez, RDEP, El Maraghi, S, Yehia, A, Bakry, M, Shoman, A, Backes, FN, Bianchin, MM, Vieira, SR, Maupoint, J, De Souza, A, Lucas, JH, Backes, AN, Klein, C, García-Guillen, FJ, Arunkumar, AS, Lozano, A, Mulder, P, Gallaher, C, Cattlin, S, Ñamendys-Silva, SA, Gordon, S, Picard, J, Fontana, V, Bond, O, Coquerel, D, Nobile, L, Mrozek, S, Delamarre, L, Maghsoudi, B, Capilla, F, Al-Saati, T, Fourcade, O, Renet, S, Dominguez-Berrot, AM, Gonzalez-Vaquero, M, Vallejo-Pascual, ME, Gupta, D, Ivory, BD, Chopra, M, Emami, M, Khaliq, W, McCarthy, J, Felderhof, CL, Do Rego, JC, MacNeil, C, Maggiorini, M, Duska, F, Department of Professional Development, ESICM, Fumis, RR, Junior, JM, Khosravi, MB, Amarante, G, Rieusset, J, Skorko, A, Sanders, S, Aron, J, Kroll, RJ, Redfearn, C, Harish, MM, Krishnan, P, Khalil, JE, Kongpolprom, N, Richard, V, Gulia, V, Lourenço, E, Duro, C, Baptista, G, Alves, A, Arminda, B, Rodrigues, M, Tamion, F, Tabatabaie, HR, Hayward, J, Baldwin, F, Gray, R, Katinakis, PA, Stijf, M, Ten Kleij, M, Jansen-Frederiks, M, Broek, R, De Bruijne, M, Mengelle, C, Spronk, PE, Sinha, K, Luney, M, Palmer, K, Keating, L, Abu-Habsa, M, Bahl, R, Baskaralingam, N, Ahmad, A, Kanapeckaite, L, Bhatti, P, Strong, AJ, Sabetiyan, G, Glace, S, Jeyabraba, S, Lewis, HF, Kostopoulos, A, Raja, M, West, A, Ely, A, Turkoglu, LM, Zolfaghari, P, Baptista, JP, Mokri, A, Marques, MP, Martins, P, Pimentel, J, Su, YC, Singer, M, Villacres, S, Stone, ME, Parsikia, A, Medar, S, O'Dea, KP, Nurses of the Central and General ICUs of Shiraz Namazi Hospital, Porter, J, Tirlapur, N, Jonathan, JM, Singh, S, Takata, M, Critical Care Research Group, McWhirter, E, Lyon, R, Troubleyn, J, Hariz, ML, Ferlitsch, A, Azmi, E, Alkhan, J, Smulders, YM, Movsisyan, V, Petrikov, S, Marutyan, Z, Aliev, I, Evdokimov, A, Antonucci, E, Diltoer, M, Merz, T, Hartmann, C, De Waard, MC, Calzia, E, Radermacher, P, Nußbaum, B, Huber-Lang, M, Fauler, G, Gröger, M, Jacobs, R, Zaleska-Kociecka, M, Van Straaten, HM, Trauner, M, Svoren-Jabalera, E, Davenport, EE, Humburg, P, Nguyen, DN, Knight, J, Hinds, CJ, Jun, IJ, Prabu, NR, Kim, WJ, Lee, EH, Besch, G, Perrotti, A, Puyraveau, M, Baltres, M, Eringa, EC, De Waele, E, Samain, E, Chocron, S, Pili-Floury, S, Plata-Menchaca, EP, Sabater-Riera, J, Estruch, M, Boza, E, Toscana-Fernández, J, Man, AM, Bruguera-Pellicer, E, De Regt, J, Ordoñez-Llanos, J, Pérez-Fernández, XL, SIRAKI group, Cavaleiro, P, Tralhão, A, Arrigo, M, Lopes, JP, Lebrun, M, Favier, B, Pischke, S, Cholley, B, PerezVela, JL, Honoré, PM, MarinMateos, H, Rivera, JJ, Llorente, MA, De Marcos, BG, Fernandez, FJ, Laborda, CG, Zamora, DF, Fischer, L, Alegría, L, Grupo ESBAGA, Delgado, JC, Imperiali, C, Myers, RB, Van Gorp, V, Dastis, M, Thaiss, F, Soto, D, Górka, J, Spapen, HD, Górka, K, Iwaniec, T, Koch, M, Frołow, M, Polok, K, Luengo, C, Fronczek, J, Kózka, M, Musiał, J, Szczeklik, W, Contreras, RS, Bangert, K, Gomez, J, Sileli, M, Havaldar, AA, Toapanta, ND, Jarufe, N, Moursia, C, Maleoglou, H, Leleki, K, Uz, Z, Ince, Y, Papatella, R, Bulent, E, Moreno, G, Grabowski, M, Bruhn, A, De Mol, B, Vicka, V, Gineityte, D, Ringaitiene, D, Norkiene, I, Sipylaite, J, Möller, C, Sabater, J, Castro, R, Thomas-Rueddel, DO, Vlasakov, V, Lohse, AW, Rochwerg, B, Theurer, P, Al Sibai, JZ, Camblor, PM, Kattan, E, Torrado, H, Siddiqui, S, Fernandez, PA, Gala, JM, Guisasola, JS, Tamura, T, Miyajima, I, Yamashita, K, Yokoyama, M, Tapia, P, Nashan, B, Gonzalez, M, Dalampini, E, Nastou, M, Baddour, A, Ignatiadis, A, Asteri, T, Hathorn, KE, Sterneck, M, Rebolledo, R, Purtle, SW, Marin, M, Viana, MV, Tonietto, TA, Gross, LA, Costa, VL, Faenza, S, Tavares, AL, Payen, D, Lisboa, BO, Moraes, RB, Farigola, E, Viana, LV, Azevedo, MJ, Ceniccola, GD, Pequeno, RS, Siniscalchi, A, Holanda, TP, Mendonça, VS, Achurra, P, Araújo, WM, Carvalho, LS, Segaran, E, Vickers, L, Gonzalez, A, Brinchmann, K, Pierucci, E, Wignall, I, De Brito-Ashurst, I, Ospina-Tascón, G, Del Olmo, R, Esteban, MJ, Vaquerizo, C, Carreño, R, Gálvez, V, Kaminsky, G, Mancini, E, Fernandez, J, Nieto, B, Fuentes, M, De la Torre, MA, Bakker, J, Torres, E, Alonso, A, Velayos, C, Saldaña, T, Escribá, A, Krishna, B, Grip, J, Kölegård, R, Vera, A, Sundblad, P, Rooyackers, O, Hernández, G, Naser, B, Jaziri, F, Jazia, AB, Barghouth, M, Ricci, D, Hentati, O, Skouri, W, El Euch, M, Mahfoudhi, M, Gisbert, X, Turki, S, Dąbrowski, M, Bertini, P, Abdelghni, KB, Abdallah, B, Gemelli, C, Maha, BN, Cánovas, J, Sotos, F, López, A, Lorente, M, Burruezo, A, Torres, D, Juliá, C, Guarracino, F, Cuoghi, A, Włudarczyk, A, Hałek, A, Bargouth, M, Bennasr, M, Baldassarri, R, Magnani, S, Uya, J, Abdelghani, KB, Abdallah, TB, Geenen, IL, Parienti, JJ, Straaten, HM, Shum, HP, King, HS, Kulkarni, AP, Pinsky, MR, Chan, KC, Corral, L, Yan, WW, Londoño, JG, Cardenas, CL, Pedrosa, MM, Gubianas, CM, Bertolin, CF, Batllori, NV, Atti, M, Sirvent, JM, Sedation an Delirium Group Hospital Universitari de Bellvitge, Mukhopadhyay, A, Chan, HY, Kowitlawakul, Y, Remani, D, Leong, CS, Henry, CJ, Vera, M, Puthucheary, ZA, Mendsaikhan, N, Begzjav, T, Elias-Jones, I, Lundeg, G, Dünser, M, Espinoza, ED, Welsh, SP, Guerra, E, Poppe, A, Zerpa, MC, Zechner, F, Berdaguer, F, Risso-Vazquez, A, Masevicius, FD, Greaney, D, Dreyse, J, Magee, A, Fitzpatrick, G, Lugo-Cob, RG, Jermaine, CM, Tejeda-Huezo, BC, Cano-Oviedo, AA, Carpio, D, Aydogan, MS, Togal, T, Taha, A, Chai, HZ, Sriram, S, Kam, C, Razali, SS, Sivasamy, V, Randall, D, Kuan, LY, Henriquez, C, Morales, MA, Pires, T, Adwaney, A, Wozniak, S, Gajardo, D, Herrera-Gutierrez, ME, Azevedo, LC, Blunden, M, Prowle, JR, Kirwan, CJ, Thomas, N, Martin, A, Owen, H, Darwin, L, Robertson, CS, Bravo, S, Barrueco-Francioni, J, Conway, D, Atkinson, D, Sharman, M, Barbanti, C, Amour, J, Gaudard, P, Rozec, B, Mauriat, P, M'rini, M, Arias-Verdú, D, Rusin, CG, Leger, PL, Cambonie, G, Liet, JM, Girard, C, Laroche, S, Damas, P, Assaf, Z, Loron, G, 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H, Kingma, WP, Navis, GJ, Boerma, EC, Rulisek, J, Zacharov, S, Kim, HS, Jeon, SJ, Namgung, H, Lee, E, Lai, M, Kačar, MB, Cho, YJ, Lee, YJ, Huang, A, Deiana, M, Forsberg, M, Edman, G, Kačar, SM, Höjer, J, Forsberg, S, Freile, MT, Hidalgo, FN, Molina, JA, Lecumberri, R, Rosselló, AF, Travieso, PM, Leon, GT, Uddin, I, Sanchez, JG, Ali, MA, Frias, LS, Rosello, DB, Verdejo, JA, Serrano, JA, Winterwerp, D, Van Galen, T, Vazin, A, Karimzade, I, Belhaj, AM, Zand, A, Ozen, E, Ekemen, S, Akcan, A, Sen, E, Yelken, BB, Kureshi, N, Fenerty, L, Thibault-Halman, G, Aydın, MA, Walling, S, Almeida, R, Seller-Perez, G, Clarke, DB, Briassoulis, P, Kalimeris, K, Ntzouvani, A, Nomikos, T, Papaparaskeva, K, Avsec, D, Politi, E, Kostopanagiotou, G, Crewdson, K, Vardas, K, Rehn, M, Vaz-Ferreira, A, Weaver, A, Brohi, K, Lockey, D, Wright, S, Thomas, K, Mudersbach, E, Baker, C, Mansfield, L, Pozo, MO, Stafford, V, Wade, C, Watson, G, Silva, J, Bryant, A, Chadwick, T, Shen, J, Wilkinson, J, Kapuağası, A, Furneval, J, and Clinical Neurophysiology

Subjects
Queen Square Neuroanaesthesia and Neurocritical Care Resreach Group, TAVeM study Group, Renal Transplantation HUVR, Flow (psychology), lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4], Critical Care and Intensive Care Medicine, Grupo ESBAGA, GEMINI, 03 medical and health sciences, chemistry.chemical_compound, SPACeR group (Surrey Peri-operative, Anaesthesia and Critical Care Collaborative Research Group), 0302 clinical medicine, Critical Care Research Group, Journal Article, PRoVENT investigators and the PROVE Network, Medicine, Sedation an Delirium Group Hospital Universitari de Bellvitge, 030212 general & internal medicine, Bioethics work group of SEMICYUC, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries), SEMICYUC/GETGAG Working Group, FINNAKI Study Group, POPC-CB investigators, business.industry, Other Research Radboud Institute for Health Sciences [Radboudumc 0], SIRAKI group, 030208 emergency & critical care medicine, EDISVAL Group, PLUG Working group, DESIRE (DExmedetomidine for Sepsis in ICU Randomized Evaluation) Trial Investigators, chemistry, Anesthesia, Carbon dioxide, Breathing, Department of Professional Development, ESICM, business, Nurses of the Central and General ICUs of Shiraz Namazi Hospital
Abstract

Contains fulltext : 172382.pdf (Publisher’s version ) (Open Access)

Published
2016

21. The Prognostic Value of Pre-Operative and Post-Operative B-Type Natriuretic Peptides in Patients Undergoing Noncardiac Surgery

Author

Rodseth, RN, Biccard, BM, Le Manach, Y, Sessler, DI, Buse, GAL, Thabane, L, Schutt, RC, Bolliger, D, Cagini, L, Cardinale, D, Chong, CPW, Chu, R, Cnotliwy, M, Di Somma, S, Fahrner, R, Lim, WK, Mahla, E, Manikandan, R, Puma, F, Pyun, WB, Radovic, M, Rajagopalan, S, Suttie, S, Vanniyasingam, T, van Gaal, WJ, Waliszek, M, Devereaux, PJ, Rodseth, RN, Biccard, BM, Le Manach, Y, Sessler, DI, Buse, GAL, Thabane, L, Schutt, RC, Bolliger, D, Cagini, L, Cardinale, D, Chong, CPW, Chu, R, Cnotliwy, M, Di Somma, S, Fahrner, R, Lim, WK, Mahla, E, Manikandan, R, Puma, F, Pyun, WB, Radovic, M, Rajagopalan, S, Suttie, S, Vanniyasingam, T, van Gaal, WJ, Waliszek, M, and Devereaux, PJ

Abstract

OBJECTIVES: The objective of this study was to determine whether measuring post-operative B-type natriuretic peptides (NPs) (i.e., B-type natriuretic peptide [BNP] and N-terminal fragment of proBNP [NT-proBNP]) enhances risk stratification in adult patients undergoing noncardiac surgery, in whom a pre-operative NP has been measured. BACKGROUND: Pre-operative NP concentrations are powerful independent predictors of perioperative cardiovascular complications, but recent studies have reported that elevated post-operative NP concentrations are independently associated with these complications. It is not clear whether there is value in measuring post-operative NP when a pre-operative measurement has been done. METHODS: We conducted a systematic review and individual patient data meta-analysis to determine whether the addition of post-operative NP levels enhanced the prediction of the composite of death and nonfatal myocardial infarction at 30 and ≥180 days after surgery. RESULTS: Eighteen eligible studies provided individual patient data (n = 2,179). Adding post-operative NP to a risk prediction model containing pre-operative NP improved model fit and risk classification at both 30 days (corrected quasi-likelihood under the independence model criterion: 1,280 to 1,204; net reclassification index: 20%; p < 0.001) and ≥180 days (corrected quasi-likelihood under the independence model criterion: 1,320 to 1,300; net reclassification index: 11%; p = 0.003). Elevated post-operative NP was the strongest independent predictor of the primary outcome at 30 days (odds ratio: 3.7; 95% confidence interval: 2.2 to 6.2; p < 0.001) and ≥180 days (odds ratio: 2.2; 95% confidence interval: 1.9 to 2.7; p < 0.001) after surgery. CONCLUSIONS: Additional post-operative NP measurement enhanced risk stratification for the composite outcomes of death or nonfatal myocardial infarction at 30 days and ≥180 days after noncardiac surgery compared with a pre-operative NP measurement alone.

Published
2014

22. The safety of addition of nitrous oxide to general anaesthesia in at-risk patients having major non-cardiac surgery (ENIGMA-II): a randomised, single-blind trial.

Author

ANZCA Clinical Trials Network, Chan, MTV, Myles, PS, Paech, MJ, Silbert, BS, Leslie, K, Forbes, A, Peyton, PJ, Beattie, S, Sessler, DI, Devereaux, PJ, Schricker, T, Wallace, S, ANZCA Trials Group for the ENIGMA-II investigators, ANZCA Clinical Trials Network, Chan, MTV, Myles, PS, Paech, MJ, Silbert, BS, Leslie, K, Forbes, A, Peyton, PJ, Beattie, S, Sessler, DI, Devereaux, PJ, Schricker, T, Wallace, S, and ANZCA Trials Group for the ENIGMA-II investigators

Abstract

BACKGROUND: Nitrous oxide is commonly used in general anaesthesia but concerns exist that it might increase perioperative cardiovascular risk. We aimed to gather evidence to establish whether nitrous oxide affects perioperative cardiovascular risk. METHODS: We did an international, randomised, assessor-blinded trial in patients aged at least 45 years with known or suspected coronary artery disease having major non-cardiac surgery. Patients were randomly assigned via automated telephone service, stratified by site, to receive a general anaesthetic with or without nitrous oxide. Attending anaesthetists were aware of patients' group assignments, but patients and assessors were not. The primary outcome measure was a composite of death and cardiovascular complications (non-fatal myocardial infarction, stroke, pulmonary embolism, or cardiac arrest) within 30 days of surgery. Our modified intention-to-treat population included all patients randomly assigned to groups and undergoing induction of general anaesthesia for surgery. This trial is registered at ClinicalTrials.gov, number NCT00430989. FINDINGS: Of 10,102 eligible patients, we enrolled 7112 patients between May 30, 2008, and Sept 28, 2013. 3543 were assigned to receive nitrous oxide and 3569 were assigned not to receive nitrous oxide. 3483 patients receiving nitrous oxide and 3509 not receiving nitrous oxide were assessed for the primary outcome. The primary outcome occurred in 283 (8%) patients receiving nitrous oxide and in 296 (8%) patients not receiving nitrous oxide (relative risk 0·96, 95% CI 0·83–1·12; p=0·64). Surgical site infection occurred in 321 (9%) patients assigned to nitrous oxide, and in 311 (9%) patients in the no-nitrous oxide group (p=0·61), and severe nausea and vomiting occurred in 506 patients (15%) assigned to nitrous oxide and 378 patients (11%) not assigned to nitrous oxide (p<0·0001). INTERPRETATION: Our findings support the safety profile of nitrous oxide use in major non-cardiac surgery

Published
2014

25. Perioperative epidural analgesia for major abdominal surgery for cancer and recurrence-free survival: randomised trial.

Author

ANZCA Clinical Trials Network, Myles, PS, Peyton, PJ, Silbert, BS, Rigg, J, Hunt, J, Rigg, JR, Sessler, DI, ANZCA Clinical Trials Network, Myles, PS, Peyton, PJ, Silbert, BS, Rigg, J, Hunt, J, Rigg, JR, and Sessler, DI

Abstract

Objective To compare long term recurrence of cancer and survival of patients having major abdominal surgery for cancer. Design Long term follow-up of prospective randomised controlled clinical trial in which patients were randomly assigned to receive general anaesthesia with or without epidural block for at least three postoperative days. Setting 23 hospitals in Australia, New Zealand, and Asia. Participants 503 adult patients who had potentially curative surgery for cancer. Main outcome measure Cancer-free survival (analysis was by intention to treat). Results Long term follow-up data were available for 94% (n=446) of eligible participants. The median time to recurrence of cancer or death was 2.8 (95% confidence interval 0.7 to 8.7) years in the control group and 2.6 (0.7 to 8.7) years in the epidural group (P=0.61). Recurrence-free survival was similar in both epidural and control groups (hazard ratio 0.95, 95% confidence interval 0.76 to 1.17; P=0.61). Conclusion Use of epidural block in abdominal surgery for cancer is not associated with improved cancer-free survival. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12607000637448

Published
2011

29. The thermoregulation story.

Author

Sessler DI

Abstract

The Thermoregulatory Threshold in Humans during Halothane Anesthesia. By Sessler DI, Olofsson CI, Rubinstein EH, Beebe JJ: ANESTHESIOLOGY 1988; 68: 836-42. Reprinted with permission.Although suppression of thermoregulatory mechanisms by anesthetics is generally assumed, the extent to which thermoregulation is active during general anesthesia is not known. The only thermoregulatory responses available to anesthetized, hypothermic patients are vasoconstriction and nonshivering thermogenesis. To test anesthetic effects on thermoregulation, the authors measured skin-surface temperature gradients (forearm temperature - fingertip temperature) as an index of cutaneous vasoconstriction in unpremedicated patients anesthetized with 1% halothane and paralyzed with vecuronium during elective, donor nephrectomy. Patients were randomly assigned to undergo maximal warming (warm room, humidified respiratory gases, and warm intravenous fluids; n = 5) or standard temperature management (no special warming measures; n = 5). Skin-surface temperature gradients of 4°C or more were prospectively defined as significant vasoconstriction. Normothermic patients (average minimum esophageal temperature = 36.4° ± 0.3°C [SD]) did not demonstrate significant vasoconstriction. However, each hypothermic patient displayed significant vasoconstriction at esophageal temperatures ranging from 34.0 to 34.8°C (average temperature = 34.4° ± 0.2°C). These data indicate that active thermoregulation occurs during halothane anesthesia, but that it does not occur until core temperature is approximately 2.5°C lower than normal. In two additional hypothermic patients, increased skin-temperature gradients correlated with decreased perfusion as measured by a laser Doppler technique. Measuring skin-surface temperature gradients is a simple, noninvasive, and quantitative method of determining the thermoregulatory threshold during anesthesia. [ABSTRACT FROM AUTHOR]

Published
2013
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31. Hospital stay and mortality are increased in patients having a 'triple low' of low blood pressure, low bispectral index, and low minimum alveolar concentration of volatile anesthesia.

Author

Sessler DI, Sigl JC, Kelley SD, Chamoun NG, Manberg PJ, Saager L, Kurz A, and Greenwald S

Abstract

BACKGROUND: Low mean arterial pressure (MAP) and deep hypnosis have been associated with complications and mortality. The normal response to high minimum alveolar concentration (MAC) fraction of anesthetics is hypotension and low Bispectral Index (BIS) scores. Low MAP and/or BIS at lower MAC fractions may represent anesthetic sensitivity. The authors sought to characterize the effect of the triple low state (low MAP and low BIS during a low MAC fraction) on duration of hospitalization and 30-day all-cause mortality. METHODS: Mean intraoperative MAP, BIS, and MAC were determined for 24,120 noncardiac surgery patients at the Cleveland Clinic, Cleveland, Ohio. The hazard ratios associated with combinations of MAP, BIS, and MAC values greater or less than a reference value were determined. The authors also evaluated the association between cumulative triple low minutes, and excess length-of-stay and 30-day mortality. RESULTS: Means (±SD) defining the reference, low, and high states were 87 ± 5 mmHg (MAP), 46 ± 4 (BIS), and 0.56 ± 0.11 (MAC). Triple lows were associated with prolonged length of stay (hazard ratio 1.5, 95% CI 1.3-1.7). Thirty-day mortality was doubled in double low combinations and quadrupled in the triple low group. Triple low duration >=60 min quadrupled 30-day mortality compared with <=15 min. Excess length of stay increased progressively from <=15 min to >=60 min of triple low. CONCLUSIONS: The occurrence of low MAP during low MAC fraction was a strong and highly significant predictor for mortality. When these occurrences were combined with low BIS, mortality risk was even greater. The values defining the triple low state were well within the range that many anesthesiologists tolerate routinely. [ABSTRACT FROM AUTHOR]

Published
2012
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33. Effects of crystalloid versus colloid and the [alpha]-2 agonist brimonidine versus placebo on intraocular pressure during prone spine surgery: a factorial randomized trial.

Author

Farag E, Sessler DI, Kovaci B, Wang L, Mascha EJ, Bell G, Kalfas I, Rockwood E, and Kurz A

Abstract

BACKGROUND: Volume replacement with colloid solution and topical [alpha]-2 agonists may each moderate the progressive increase in intraocular pressure (IOP) during prone surgery. The authors tested the hypotheses that during prolonged prone surgery, IOP increases less with goal-directed intravenous administration of 5% albumin than with goal-directed administration of lactated Ringer's solution, and with topical [alpha]-2 agonist brimonidine than with placebo eye drops. METHODS: Patients having complex prone spine surgery were factorially randomized to albumin and topical placebo (n = 15); albumin and topical brimonidine (n = 16); lactated Ringer's solution and topical placebo (n = 13); and lactated Ringer's solution and topical brimonidine (n = 16). IOP was measured with a pneumotonometer. The primary outcome was time-weighted average intraoperative IOP. RESULTS: Prone positioning increased IOP a mean ± SD of 12 ± 6 mmHg. IOP increased to 38 ± 10 mmHg at the end of anesthesia (approximately 5.5 h). Time- weighted average intraoperative IOP in the brimonidine group was 4 (95% CI: 1, 8) mmHg lower than in the placebo group (P = 0.023), but no different in the crystalloid and albumin groups (mean difference (95% CI) of -2 (-5, 2) mmHg (P = 0.34). There was no interaction between the two randomized factors. CONCLUSIONS: Brimonidine slightly reduced the primary outcome of intraoperative time-weighted average IOP, whereas there was no significant difference between goal-directed albumin or crystalloid administration. Brimonidine thus helps reduce IOP during spine surgery, but maintaining adequate blood pressure might play a more important role. [ABSTRACT FROM AUTHOR]

Published
2012
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42. Long-term pain, stiffness, and functional disability after total knee arthroplasty with and without an extended ambulatory continuous femoral nerve block: a prospective, 1-year follow-up of a multicenter, randomized, triple-masked, placebo-controlled...

Author

Ilfeld BM, Shuster JJ, Theriaque DW, Mariano ER, Girard PJ, Loland VJ, Meyer S, Donovan JF, Pugh GA, Le LT, Sessler DI, Ball ST, Ilfeld, Brian M, Shuster, Jonathan J, Theriaque, Douglas W, Mariano, Edward R, Girard, Paul J, Loland, Vanessa J, Meyer, Scott, and Donovan, John F

Abstract

Background: Previously, we have demonstrated that extending a continuous femoral nerve block (cFNB) from overnight to 4 days after total knee arthroplasty (TKA) provides clear benefits during the infusion, but not subsequent to catheter removal. However, there were major limitations in generalizing the results of that investigation, and we subsequently performed a very similar study using a multicenter format, with many health care providers, in patients on general orthopedic wards, thus greatly improving inference of the results to the general population. Not surprisingly, the perioperative/short-term outcomes differed greatly from the first, more limited study. We now present a prospective follow-up study of the previously published, multicenter, randomized controlled clinical trial to investigate the possibility that an extended ambulatory cFNB decreases long-term pain, stiffness, and functional disability after TKA, which greatly improves inference of the results to the general population.Methods: Subjects undergoing TKA received a cFNB with ropivacaine 0.2% from surgery until the following morning, at which time patients were randomized to continue either perineural ropivacaine (n=28) or normal saline (n=26). Patients were discharged with their catheter and a portable infusion pump, and catheters were removed on postoperative day 4. Health-related quality of life was measured using the Western Ontario and McMaster Universities Osteoarthritis Index preoperatively and then at 7 days, as well as 1, 2, 3, 6, and 12 months after surgery. This index evaluates pain, stiffness, and physical functional disability. For inclusion in the analysis, we required a minimum of 4 of the 6 time points, including day 7 and at least 2 of months 3, 6, and 12.Results: The 2 treatment groups had similar Western Ontario and McMaster Universities Osteoarthritis scores for the mean area-under-the-curve calculations (point estimate for the difference in mean area under the curve for the 2 groups [overnight infusion group - extended infusion group]=3.8; 95% confidence interval, -3.8 to +11.3; P=0.32) and at all individual time points (P>0.05).Conclusions: This investigation found no evidence that extending an overnight cFNB to 4 days improves (or worsens) subsequent pain, stiffness, or physical function after TKA in patients of multiple centers convalescing on general orthopedic wards. [ABSTRACT FROM AUTHOR]

Published
2011

47. A comparison of the Airway Scope and McCoy laryngoscope in patients with simulated restricted neck mobility.

Author

Komatsu R, Kamata K, Sessler DI, Ozaki M, Komatsu, R, Kamata, K, Sessler, D I, and Ozaki, M

Abstract

We compared the efficacy of the Airway Scope and McCoy laryngoscope as intubation tools with the neck stabilised by a rigid cervical collar. After induction of anaesthesia and neck stabilisation, 100 patients were randomly assigned to tracheal intubation with an Airway Scope or McCoy laryngoscope. Overall intubation success rate, time required for intubation, number of intubation attempts required for successful intubation, and airway complications related to intubation were recorded. Overall intubation success rates were 100% with both devices and a similar number of intubation attempts were required. However, the mean (SD) time required for successful intubation was shorter with the Airway Scope (30 (7) s) than with the McCoy laryngoscope (40 (14) s; p < 0.0001). The incidences of intubation complications were similar, but oesophageal intubation (in six cases) occurred only with McCoy laryngoscope. [ABSTRACT FROM AUTHOR]

Published
2010
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