Abstract

BackgroundAcetylcholinesterase inhibitors cannot rapidly reverse profound neuromuscular block. Sugammadex, a selective relaxant binding agent, reverses the effects of rocuronium and vecuronium by encapsulation. This study assessed the efficacy of sugammadex compared with neostigmine in reversal of profound vecuronium-induced neuromuscular block under sevoflurane anesthesia.MethodsPatients aged ≥18 years, American Society of Anesthesiologists class 1-4, scheduled to undergo surgery under general anesthesia were enrolled in this phase III, multicenter, randomized, safety-assessor blinded study. Sevoflurane anesthetized patients received vecuronium 0.1 mg/kg for intubation, with maintenance doses of 0.015 mg/kg as required. Patients were randomized to receive sugammadex 4 mg/kg or neostigmine 70 μg/kg with glycopyrrolate 14 μg/kg at 1-2 post-tetanic counts. The primary efficacy variable was time from start of study drug administration to recovery of the train-of-four ratio to 0.9. Safety assessments included physical examination, laboratory data, vital signs, and adverse events.ResultsEighty three patients were included in the intent-to-treat population (sugammadex, n = 47; neostigmine, n = 36). Geometric mean time to recovery of the train-of-four ratio to 0.9 was 15-fold faster with sugammadex (4.5 minutes) compared with neostigmine (66.2 minutes; p < 0.0001) (median, 3.3 minutes with sugammadex versus 49.9 minutes with neostigmine). No serious drug-related adverse events occurred in either group.ConclusionsRecovery from profound vecuronium-induced block is significantly faster with sugammadex, compared with neostigmine. Neostigmine did not rapidly reverse profound neuromuscular block (Trial registration number: NCT00473694).

Highlights

  • Acetylcholinesterase inhibitors cannot rapidly reverse profound neuromuscular block

  • Anesthesiologists are limited in their capacity to provide such levels of neuromuscular block towards the end of surgery in particular, because the traditional agents available for the reversal of neuromuscular block cannot rapidly reverse profound block [1]

  • Patients were excluded if they had a neuromuscular disorder; a history of malignant hyperthermia; significant renal dysfunction; an allergy to narcotics, muscle relaxants, or other medication used during general anesthesia; were using medication known to interfere with neuromuscular blocking agents; or were pregnant, breast feeding, or of childbearing potential and not using an adequate method of contraception

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Summary

Introduction

Acetylcholinesterase inhibitors cannot rapidly reverse profound neuromuscular block. Sugammadex, a selective relaxant binding agent, reverses the effects of rocuronium and vecuronium by encapsulation. This study assessed the efficacy of sugammadex compared with neostigmine in reversal of profound vecuronium-induced neuromuscular block under sevoflurane anesthesia. Anesthesiologists are limited in their capacity to provide such levels of neuromuscular block towards the end of surgery in particular, because the traditional agents available for the reversal of neuromuscular block (acetylcholinesterase inhibitors) cannot rapidly reverse profound block [1]. This is especially important if volatile anesthetics have been used as they are known to Sugammadex is a new selective relaxant binding agent. A single dose-finding study has examined the efficacy of sugammadex to reverse profound block induced by vecuronium [3]

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