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2. Naloxone for Opioid Overdose: Reply

Author

van Lemmen, Maarten, Florian, Jeffrey, Li, Zhihua, van Velzen, Monique, van Dorp, Eveline, Niesters, Marieke, Sarton, Elise, Olofsen, Erik, van der Schrier, Rutger, Strauss, David G., and Dahan, Albert

Published
2024
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9. Cannabis combined with oxycodone for pain relief in fibromyalgia pain: a randomized clinical self-titration trial with focus on adverse events.

Author

van Dam, Cornelis Jan, Kramers, Cornelis, Schellekens, Arnt, Bouvy, Marcel, van Dorp, Eveline, Kowal, Mikael A., Olofsen, Erik, Dahan, Albert, Niesters, Marieke, and van Velzen, Monique

Abstract

Objectives: We determined whether adding cannabis to oxycodone for chronic non-cancer pain management could reduce treatment-related adverse effects (AEs) while maintaining effective analgesia. Methods: In this open-label study, fibromyalgia patients aged ≥18 years were randomized to receive 5 mg oxycodone tablets (max. four times/day), 150 mg of inhaled cannabis containing 6.3% Δ9-tetrahydrocannabinol and 8% cannabidiol (max. times inhalation sessions/day), or a combination of both for 6 weeks. The primary endpoint was treatment-related adverse events, assessed using a 10-point composite adverse event (cAE) score; additionally, we recorded daily reported pain relief and daily tablet and cannabis consumption. Results: In total, 23 patients were treated with oxycodone, 29 with cannabis, and 29 with the oxycodone/cannabis combination. Three patients from the oxycodone group (13%) and 18 patients from the cannabis groups (31%, 9 in each group) withdrew from the trial within 2–3 weeks because of the severity of AEs. There were no differences in treatment-related cAE scores among the three groups that completed the study (p = 0.70). The analgesic responder rate showed a ≥1- point reduction in pain in 50% and a ≥2-point reduction in 20% of patients, while 50% of patients experienced no treatment benefit. The combination treatment reduced oxycodone tablet consumption by 35% (p = 0.02), but it did not affect the number of cannabis inhalation sessions. Conclusions: Cannabis combined with oxycodone offered no advantage over either treatment alone, except for a reduction in opioid tablet intake; however, the overall drug load was the highest in the combination group. Moreover, cannabis was poorly tolerated and led to treatment discontinuation in one-third of participants treated with cannabis. Clinical Trial Registration: The trial was registered at the WHO International Clinical Trials Registry Platform (trialsearch.who.int) on July 26, 2019, identifier NL7902. [ABSTRACT FROM AUTHOR]

Published
2024
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13. Reversal of Propofol-induced Depression of the Hypoxic Ventilatory Response by BK-channel Blocker ENA-001: A Randomized Controlled Trial

Author

Jansen, Simone, van Lemmen, Maarten, Olofsen, Erik, Moss, Laurence, Pergolizzi, Joseph, Miller, Thomas, Colucci, Robert, van Velzen, Monique, Kremer, Philip, Dahan, Albert, van der Schrier, Rutger, Niesters, Marieke, Jansen, Simone, van Lemmen, Maarten, Olofsen, Erik, Moss, Laurence, Pergolizzi, Joseph, Miller, Thomas, Colucci, Robert, van Velzen, Monique, Kremer, Philip, Dahan, Albert, van der Schrier, Rutger, and Niesters, Marieke

Abstract

BACKGROUND: The use of anesthetics may result in depression of the hypoxic ventilatory response. Since there are no receptor-specific antagonists for most anesthetics, there is the need for agnostic respiratory stimulants that increase respiratory drive irrespective of its cause. The authors tested whether ENA-001, an agnostic respiratory stimulant that blocks carotid body BK-channels, could restore the hypoxic ventilatory response during propofol infusion. They hypothesize that ENA-001 is able to fully restore the hypoxic ventilatory response. METHODS: In this randomized, double-blind crossover trial, 14 male and female healthy volunteers were randomized to receive placebo and low- and high-dose ENA-001 on three separate occasions. On each occasion, isohypercapnic hypoxic ventilatory responses were measured during a fixed sequence of placebo, followed by low- and high-dose propofol infusion. The authors conducted a population pharmacokinetic/pharmacodynamic analysis that included oxygen and carbon dioxide kinetics. RESULTS: Twelve subjects completed the three sessions; no serious adverse events occurred. The propofol concentrations were 0.6 and 2.0 µg/ml at low and high dose, respectively. The ENA-001 concentrations were 0.6 and 1.0 µg/ml at low and high dose, respectively. The propofol concentration that reduced the hypoxic ventilatory response by 50% was 1.47 ± 0.20 µg/ml. The steady state ENA-001 concentration to increase the depressed ventilatory response by 50% was 0.51 ± 0.04 µg/ml. A concentration of 1 µg/ml ENA-001 was required for full reversal of the propofol effect at the propofol concentration that reduced the hypoxic ventilatory response by 50%. CONCLUSIONS: In this pilot study, the authors demonstrated that ENA-001 restored the hypoxic ventilatory response impaired by propofol. This finding is not only of clinical importance but also provides mechanistic insights into the peripheral stimulation of breathing with ENA-001 overcoming central depression b

Published
2024

14. Design thinking in medical education to tackle real world healthcare problems: The MasterMinds Challenge

Author

van Velzen, Monique (author), Boru, A. (author), Sarton, Elise (author), de Beaufort, Arnout Jan (author), van Velzen, Monique (author), Boru, A. (author), Sarton, Elise (author), and de Beaufort, Arnout Jan (author)

Abstract

Educational challenge: Medical education must equip future professionals with the necessary skills to navigate the complex healthcare landscape. Clinical knowledge is essential, and critical and creative thinking skills are vital to meet the challenges of the system. Design thinking offers a structured approach that integrates creativity and innovation, yet its application in medical education is absent. Solution and implementation: The compulsory MasterMinds Challenge course at Leiden University Medical Center utilizes design thinking principles to address real world healthcare challenges. Final-year medical students participated in a two-day program. The course encompassed empathizing with stakeholders, problem definition, ideation, prototyping, and refining solutions. Presentation skills were emphasized, culminating in a symposium where teams showcase their outcomes. Implementation of the MasterMinds Challenge course was successful with 33 sessions delivered to 1217 medical students. Challenges covered various healthcare topics, yielding creative yet practical outcomes. Students appreciate the real world healthcare challenge, team-based approach, and the applicability of design thinking principles. Challenge owners expressed satisfaction with students’ commitment, creativity, and empathizing abilities. Lessons learned and next steps: To further enhance the MasterMinds Challenge course, a more longitudinal format is being designed, enabling greater autonomy and emphasizing the refining and implementation phases. The course can be extended to medical postgraduate professionals and interdisciplinary collaborations, fostering innovative ideas beyond current practices. By developing problem-solving skills, the MasterMinds Challenge course contributes to a future-proof medical education program and prepares students to meet the evolving needs of healthcare., Delft Centre for Entrepreneurship

Published
2024
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20. The impact of deep versus standard neuromuscular block on intraoperative safety during laparoscopic surgery: an international multicenter randomized controlled double-blind strategy trial — EURO-RELAX TRIAL

Author

Honing, Maarten, Reijnders-Boerboom, Gabby, Dell-Kuster, Salome, van Velzen, Monique, Martini, Chris, Valenza, Franco, Proto, Paolo, Cambronero, Oscar Díaz, Broens, Suzanne, Panhuizen, Ivo, Roozekrans, Margot, Fuchs-Buder, Thomas, Boon, Martijn, Dahan, Albert, and Warlé, Michiel

Published
2021
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23. Ketamine Pharmacokinetics: A Systematic Review of the Literature, Meta-analysis, and Population Analysis

Author

Kamp, Jasper, Olofsen, Erik, Henthorn, Thomas K., van Velzen, Monique, Niesters, Marieke, Dahan, Albert, Backman, Janne T., Drover, David R., Elkomy, Mohammed H., Fanta, Samuel, Flint, Robert B., Gustafsson, Lars L., Hammer, Gregory B., Herd, David W., Kalso, Eija, Mathôt, Ron A.A., Olkkola, Klaus, Peltoniemi, Marko, Persson, Jan, Ramamoorthy, Chandra, Saari, Teijo I., and Sherwin, Catherine M.T.

Published
2020
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33. Design thinking in medical education to tackle real world healthcare problems: The MasterMinds Challenge.

Author

van Velzen, Monique, Boru, Asli, Sarton, Elise, and de Beaufort, Arnout Jan

Subjects
*TEAMS in the workplace, *MEDICAL education, *DIFFUSION of innovations, *SATISFACTION, *AUTONOMY (Psychology), *INTERPROFESSIONAL relations, *MEDICAL care, *COURSE evaluation (Education), *PROBLEM solving, *CREATIVE ability, *MEDICAL students, *CLINICAL competence, *COMMITMENT (Psychology), *QUALITY assurance, *CRITICAL thinking, *HEALTH care teams
Abstract

Medical education must equip future professionals with the necessary skills to navigate the complex healthcare landscape. Clinical knowledge is essential, and critical and creative thinking skills are vital to meet the challenges of the system. Design thinking offers a structured approach that integrates creativity and innovation, yet its application in medical education is absent. The compulsory MasterMinds Challenge course at Leiden University Medical Center utilizes design thinking principles to address real world healthcare challenges. Final-year medical students participated in a two-day program. The course encompassed empathizing with stakeholders, problem definition, ideation, prototyping, and refining solutions. Presentation skills were emphasized, culminating in a symposium where teams showcase their outcomes. Implementation of the MasterMinds Challenge course was successful with 33 sessions delivered to 1217 medical students. Challenges covered various healthcare topics, yielding creative yet practical outcomes. Students appreciate the real world healthcare challenge, team-based approach, and the applicability of design thinking principles. Challenge owners expressed satisfaction with students' commitment, creativity, and empathizing abilities. To further enhance the MasterMinds Challenge course, a more longitudinal format is being designed, enabling greater autonomy and emphasizing the refining and implementation phases. The course can be extended to medical postgraduate professionals and interdisciplinary collaborations, fostering innovative ideas beyond current practices. By developing problem-solving skills, the MasterMinds Challenge course contributes to a future-proof medical education program and prepares students to meet the evolving needs of healthcare. [ABSTRACT FROM AUTHOR]

Published
2024
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39. Respiratory Effects of Biased Ligand Oliceridine in Older Volunteers: A Pharmacokinetic–Pharmacodynamic Comparison with Morphine

Author

Simons, Pieter, primary, van der Schrier, Rutger, additional, van Lemmen, Maarten, additional, Jansen, Simone, additional, Kuijpers, Kiki W.K., additional, van Velzen, Monique, additional, Sarton, Elise, additional, Nicklas, Todd, additional, Michalsky, Cathy, additional, Demitrack, Mark A., additional, Fossler, Michael, additional, Olofsen, Erik, additional, Niesters, Marieke, additional, and Dahan, Albert, additional

Published
2022
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49. Respiratory Effects of the Atypical Tricyclic Antidepressant Tianeptine in Human Models of Opioid-induced Respiratory Depression

Author

Algera, Hyke, primary, van der Schrier, Rutger, additional, Cavalla, David, additional, van Velzen, Monique, additional, Roozekrans, Margot, additional, McMorn, Alison, additional, Snape, Michael, additional, Horrigan, Joseph P., additional, Evans, Stuart, additional, Kiernan, Bernard, additional, Sarton, Elise, additional, Olofsen, Erik, additional, Niesters, Marieke, additional, and Dahan, Albert, additional

Published
2022
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50. S-Ketamine Oral Thin Film—Part 1: Population Pharmacokinetics of S-Ketamine, S-Norketamine and S-Hydroxynorketamine

Author

Simons, Pieter, primary, Olofsen, Erik, additional, van Velzen, Monique, additional, van Lemmen, Maarten, additional, Mooren, René, additional, van Dasselaar, Tom, additional, Mohr, Patrick, additional, Hammes, Florian, additional, van der Schrier, Rutger, additional, Niesters, Marieke, additional, and Dahan, Albert, additional

Published
2022
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