TY - JOUR
T1 - Reversal of profound vecuronium-induced neuromuscular block under sevoflurane anesthesia
T2 - Sugammadex versus neostigmine
AU - Lemmens, Hendrikus J.M.
AU - El-Orbany, Mohammad I.
AU - Berry, James
AU - Morte, Jovino B.
AU - Martin, Gavin
N1 - Funding Information:
This study was supported by Merck Research Laboratories, Summit, New Jersey, US. The authors would like to thank the following investigators and colleagues for their help in the enrollment of patients: Dr. R. Kevin Jones, MD (Saddleback Memorial Medical Center, Laguna Hills, CA, US), Professor James E. Caldwell MB ChB (University of California, San Francisco, CA, US), Professor Sorin J. Brull MD (Mayo Clinic, St. Luke’s Hospital, Jacksonville, FL, US), Dr. Roy Soto MD (SUNY at Stony Brook, Health Sciences Center, Stony Brook, NY, US), Ninos J. Joseph BS (Advocate Illinois Masonic Medical Center, Chicago, IL, US). The statistical analysis of the study data was conducted by Jin-yi Chen MSc (Principal Statistician, Merck Research Laboratories, Summit, New Jersey, US. The clinical research scientist for the study was Jovino Ben Morte MD, Merck Research Laboratories, Summit, New Jersey, US. Editorial support was provided by Melanie More at Prime Medica Ltd (Knutsford, Cheshire, UK) during the preparation of this manuscript, supported by Merck, Kenilworth, New Jersey, US. Responsibility for opinions, conclusions, and interpretation of the data lies with the authors.
PY - 2010/9/1
Y1 - 2010/9/1
N2 - Background: 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.Methods: Patients 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.Results: Eighty 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.Conclusions: Recovery 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).
AB - Background: 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.Methods: Patients 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.Results: Eighty 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.Conclusions: Recovery 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).
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U2 - 10.1186/1471-2253-10-15
DO - 10.1186/1471-2253-10-15
M3 - Article
C2 - 20809967
AN - SCOPUS:77956473375
SN - 1471-2253
VL - 10
JO - BMC Anesthesiology
JF - BMC Anesthesiology
M1 - 15
ER -