Abstract
BackgroundThis randomized, double-blind trial evaluated sugammadex-mediated recovery time from rocuronium- or vecuronium-induced moderate (M-) or deep (D-) neuromuscular block in morbidly obese adults dosed by actual (ABW) or ideal body weight (IBW).MethodsAdults with BMI ≥40 kg/m2 were randomized to 1 of 5 groups: M-neuromuscular block, sugammadex 2 mg/kg ABW; M-neuromuscular block, sugammadex 2 mg/kg IBW; M-neuromuscular block, neostigmine 5 mg, and glycopyrrolate 1 mg; D-neuromuscular block, sugammadex 4 mg/kg ABW; or D-neuromuscular block, sugammadex 4 mg/kg IBW. Supramaximal train of four (TOF) stimulation of the ulnar nerve (TOF-watch SX®) monitored recovery. Primary endpoint was time to TOF ratio ≥ 0.9 for ABW and IBW groups pooled across neuromuscular blocking agent (NMBA)/blocking depth, analyzed by log-rank test stratified for agent and depth. Prespecified safety outcomes included treatment-emergent bradycardia, tachycardia, and other arrhythmias, and adjudicated hypersensitivity and anaphylaxis.ResultsOf 207 patients randomized, 188 received treatment (28% male, BMI 47 ± 5.1 kg/m2, age 48 ± 13 years). Recovery was 1.5 min faster with ABW vs IBW dosing. The sugammadex 2 mg/kg groups recovered 9-fold faster [time 0.11-fold, 95% CI 0.08 to 0.14] than the neostigmine group. ABW (5.3%) and IBW (2.7%) groups had similar incidences of recovery time > 10 min (95% CI of difference: − 4.8 to 11.0%); 84% for neostigmine group. Re-curarization occurred in one patient each in the 2 mg/kg IBW and neostigmine groups. Prespecified safety outcomes occurred with similar incidences.ConclusionsABW-based sugammadex dosing yields faster reversal without re-curarization, supporting ABW-based sugammadex dosing in the morbidly obese, irrespective of the depth of neuromuscular block or NMBA used.Trial registrationRegistered on November 17, 2017, at ClinicalTrials.gov under number NCT03346070.
Highlights
This randomized, double-blind trial evaluated sugammadex-mediated recovery time from rocuronium- or vecuronium-induced moderate (M-) or deep (D-) neuromuscular block in morbidly obese adults dosed by actual (ABW) or ideal body weight (IBW)
The sugammadex 2 mg/kg groups recovered 9-fold faster [time 0.11-fold, 95% confidence interval (95% CI) 0.08 to 0.14] than the neostigmine group
Recurarization occurred in one patient each in the 2 mg/kg IBW and neostigmine groups
Summary
This randomized, double-blind trial evaluated sugammadex-mediated recovery time from rocuronium- or vecuronium-induced moderate (M-) or deep (D-) neuromuscular block in morbidly obese adults dosed by actual (ABW) or ideal body weight (IBW). Sugammadex (Bridion®, Merck & Co., Inc., Kenilworth, NJ, USA), a modified cyclodextrin, reverses neuromuscular blockade from the neuromuscular blocking agents (NMBA), rocuronium and vecuronium. Morbid obesity (body mass index [BMI] > 40 m2/kg) alters anatomy and physiology. In morbidly obese individuals, increased lean body weight accounts for 20–40% of the excess actual body weight (ABW) [1, 2], leading to increased cardiac output [3] and drug clearance [4]. Alterations in regional blood flow in drug movement among body compartments impact the pharmacokinetics and pharmacodynamics of anesthetics, including volume of distribution and context-sensitive half-times
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