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

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Summary

Introduction

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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