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Background: Sugammadex, with its novel mechanism of action of encapsulation and noncompetitive binding of aminosteroid neuromuscular-blocking agents (rocuronium and vecuronium), may offer distinct advantage to pediatric patients where residual neuromuscular blockade may be poorly tolerated. Data describing its use in the pediatric population are limited, and no large-scale studies are available evaluating the occurrence of adverse event across the full spectrum of ages. We sought to measure the occurrence of adverse events, assess the severity and clinical significance of the events, and quantify a surrogate measure of efficacy of sugammadex compared to neostigmine in a large population and in the full age range of children., Methods: Beginning in September 2016 through initiation of data collection, we identified from our data warehouse that all patients were treated with sugammadex for reversal of neuromuscular blockade, from birth through adolescence, and retrospectively matched, by case type and age group, to historical neostigmine-treated controls. From subsequent chart review, we quantified occurrence of adverse events and administration of medications to treat adverse events. All cases in the originally identified cohort treated with epinephrine after administration of sugammadex underwent chart review to elicit the cause, in the event that an infrequently occurring event was not captured after the case-matching process. "End-Interval Time," the time from administration of reversal agent to time out of the procedure room, was measured as an indirect assessment of efficacy., Results: Fewer cases of bradycardia were observed in the sugammadex group compared to the neostigmine group in the overall cohort (P < .001) and in the subgroups of older children (P < .001) and adolescents (P < .001). End-interval time, the time measured from administration of neuromuscular blockade (NMB) reversal agent to time out of the operating room, was significantly shorter in sugammadex-treated groups in the overall cohort (mean difference, 2.8; 95% CI, 1.85-3.77; P < .001) and all age groups except for first year (31 days through 12 months). This observation was most pronounced in the neonatal subgroup (mean difference, 11.94 minutes; 95% CI, 4.79-19.1; P < .001). No other adverse events measured were found to be different between treatment groups., Conclusions: This study provides data supporting the safe and effective use of sugammadex for reversal of neuromuscular blockade throughout the entire range of ages in the pediatric population. Within age groups, sugammadex demonstrates faster completion of operation compared with neostigmine, with the greatest difference observed in the neonatal population.

Background: Noise in the operating room may cause distractions during critical periods and impair reliable communication between staff. Even momentary inefficiency while administering anesthesia can lead to errors and serious consequences for the patient. Distractions to an anesthesia provider during critical periods such as induction and emergence are a patient safety issue. Because of concerns regarding unacceptable noise levels and distractions during induction of general anesthesia, our institution developed a quality improvement initiative, the "Distraction-Free Induction Zone." The specific aim of this project was to decrease the percentage of cases with a distraction, described as music, unnecessary conversations, or loud noises, occurring during induction of general anesthesia in pediatric otolaryngology operating rooms from 61% to 15%., Methods: To complete this quality improvement initiative, a multidisciplinary team used improvement science methods, including The Model for Improvement with interventions tested via Plan-Do-Study-Act cycles. We used tools such as the Key Driver Diagram, Pareto Charts, Process Flow Chart, and Plan-Do-Study-Act worksheets. Data were manually collected and entered weekly in an Excel spreadsheet. Statistical process control methods, including a run chart and a P-control chart, were used for data analysis. Our measure was a composite measure in which observation of 1 of the 3 distractions during induction of general anesthesia categorized the case as a case with a distraction., Results: We tested and implemented several interventions via Plan-Do-Study-Act cycles in which 3 main interventions collectively were associated with an observed decrease in distractions during induction of general anesthesia. These included educating the perioperative staff present in the operating room to help them understand that distractions to anesthesia providers represent a patient safety issue, the operating room circulating nurse taking responsibility to pause any music on arrival to the operating room, and the anesthesiologist reminding the staff in the operating room of induction time and/or asking for quiet during induction if a distraction occurs. The percentage of cases with a distraction during induction of general anesthesia in our pediatric otolaryngology operating rooms decreased from 61% to 15% by April 15, 2017 and to 10% by June 5, 2017., Conclusions: Using improvement science methods, we observed a decrease in distractions during induction of general anesthesia, improved a process, and encouraged change in culture at a large academic children's hospital to enhance the quality and safety of the anesthetic care we provide our patients.

Activated protein C (aPC) resistance is a recognized hypercoagulable phenotype that is associated with increased risk for thrombosis in multiple clinical settings. Factor V Leiden (FVL) represents a specific inherited cause of aPC resistance, but the perioperative thrombotic risk of FVL is unclear. In this investigation, we sought to quantify whether cardiopulmonary bypass produces alterations in aPC resistance in FVL carriers and noncarrier controls, testing the hypothesis that FVL is associated with a relatively hypercoagulable postoperative state. Two-hundred-five adult cardiac surgery patients were prospectively enrolled into a genetic registry whose purpose was to study the impact of genetic variables on clinical outcomes. For this study, 8 subjects heterozygous for FVL were identified (group L), as well as 2 control groups: group MC, matched controls, 18 matched subjects without FVL; and group UC, unmatched controls, 11 consecutive subjects without FVL. Plasma was sampled at the beginning of surgery, 10 min after protamine administration, and on postoperative day 1, and assayed for resistance to aPC (normal aPC ratio is >2.0). Both MC and UC groups exhibited normal aPC ratio at baseline (2.40 and 2.36, respectively), which increased significantly (to 2.76 and 2.75, P = 0.007 and 0.021, respectively) on postoperative day 1, indicating increased postoperative sensitivity to aPC. Conversely, group L subjects exhibited aPC resistance at baseline (aPC ratio 1.80), and did not change significantly postoperatively (P = 0.867). Patients without FVL therefore show laboratory evidence consistent with relative protection from postoperative thrombosis, whereas FVL carriers do not. These findings provide mechanistic support for previous speculations of increased postoperative thrombotic risk associated with FVL.

Factor V Leiden (FVL) is the most common known inherited cause of thrombophilia; it is present in approximately 5% of the Caucasian population. Although the risk of venous thrombosis associated with this polymorphism in various medical settings is well described, its effect on perioperative risk is only beginning to be explored. Specifically, there are few studies addressing the potential risks of FVL in the surgical population, in which both hemorrhagic and thrombotic complications convey substantial clinical and economic significance. There are speculations and unproven hypotheses regarding FVL in this population, and these therefore highlight the need to comprehensively address this issue. This review will describe the physiology of the FVL mutation, briefly clarify its risk in the nonsurgical setting, and assess current data regarding FVL in noncardiac and cardiac surgery. Finally, a summary of current clinical evidence and a plan for more detailed investigation of this potentially significant risk factor will be proposed.