title: Rocuronium blockade reversal with sugammadex vs. neostigmine: randomized study in Chinese and Caucasian subjects.
abstract: BACKGROUND
  This study compared efficacy and safety of the selective relaxant binding agent sugammadex (2 mg/kg) with neostigmine (50 μg/kg) for neuromuscular blockade (NMB) reversal in Chinese and Caucasian subjects.
  
  
  METHODS
  This was a randomized, active-controlled, multicenter, safety-assessor-blinded study (NCT00825812) in American Society of Anesthesiologists Class 1-3 subjects undergoing surgery with propofol anesthesia. Rocuronium 0.6 mg/kg was administered for endotracheal intubation, with 0.1-0.2 mg/kg maintenance doses given as required. NMB was monitored using TOF-Watch(®) SX. At second twitch reappearance, after last rocuronium dose, subjects received sugammadex 2 mg/kg or neostigmine 50 μg/kg plus atropine 10-20 μg/kg, according to randomization. Primary efficacy variable was time from sugammadex/neostigmine to recovery of the train-of-four (TOF) ratio to 0.9.
  
  
  RESULTS
  Overall, 230 Chinese subjects (sugammadex, n = 119, neostigmine, n = 111); and 59 Caucasian subjects (sugammadex, n = 29, neostigmine, n = 30) had evaluable data. Geometric mean (95% CI) time to recovery to TOF ratio 0.9 was 1.6 (1.5-1.7) min with sugammadex vs 9.1 (8.0-10.3) min with neostigmine in Chinese subjects. Corresponding times for Caucasian subjects were 1.4 (1.3-1.5) min and 6.7 (5.5-8.0) min, respectively. Sugammadex 2 mg/kg was generally well tolerated, with no serious adverse events reported. There was no residual NMB or recurrence of NMB.
  
  
  CONCLUSIONS
  Both Chinese and Caucasian subjects recovered from NMB significantly faster after sugammadex 2 mg/kg vs neostigmine 50 μg/kg, with a ~5.7 times (p < 0.0001) faster recovery with sugammadex vs neostigmine in Chinese subjects. Sugammadex was generally well tolerated.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT00825812.
authors.affiliation: Peking University First Hospital, No 8 Xishiku St, Beijing 100034, China.
authors.forename: Xinmin
authors.initials: X
authors.lastname: Wu
authors.affiliation: Department of Anaesthesiology, Vejle Hospital, Vejle, Denmark.
authors.forename: Helle
authors.initials: H
authors.lastname: Oerding
authors.affiliation: West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Jin
authors.initials: J
authors.lastname: Liu
authors.affiliation: Department of Anesthesiology, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Bernard
authors.initials: B
authors.lastname: Vanacker
authors.affiliation: Union Hospital, Tongji Medical College, Wuhan, China.
authors.forename: Shanglong
authors.initials: S
authors.lastname: Yao
authors.affiliation: Anaesthesia and Intensive Care, Asker and Baerum Hospital, Oslo, Norway.
authors.forename: Vegard
authors.initials: V
authors.lastname: Dahl
authors.affiliation: Department of Anesthesiology, Xijing Hospital, The Fourth Military Medical University, Xi'an, China.
authors.forename: Lize
authors.initials: L
authors.lastname: Xiong
authors.affiliation: Department of Anaesthesia, Hillerød Hospital, Hillerød, Denmark.
authors.forename: Casper
authors.initials: C
authors.lastname: Claudius
authors.affiliation: Beijing Chaoyang Hospital, Beijing, China.
authors.forename: Yun
authors.initials: Y
authors.lastname: Yue
authors.affiliation: Peking Union Medical College Hospital, Beijing, China.
authors.forename: Yuguang
authors.initials: Y
authors.lastname: Huang
authors.affiliation: MSD, Oss, The Netherlands.
authors.forename: Esther
authors.initials: E
authors.lastname: Abels
authors.affiliation: MSD, Oss, The Netherlands.
authors.forename: Henk
authors.initials: H
authors.lastname: Rietbergen
authors.affiliation: Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA.
authors.forename: Tiffany
authors.initials: T
authors.lastname: Woo
mesh_terms: D000328:Adult; D000368:Aged; D000732:Androstanols / Q000037:antagonists & inhibitors*; D044466:Asian People; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009388:Neostigmine / Q000009:adverse effects / Q000494:pharmacology*; D019148:Neuromuscular Blockade / Q000379:methods*; D003473:Neuromuscular Nondepolarizing Agents / Q000037:antagonists & inhibitors*; D010277:Parasympathomimetics / Q000494:pharmacology*; D000077123:Rocuronium; D000077122:Sugammadex; D016896:Treatment Outcome; D044465:White People; D047408:gamma-Cyclodextrins / Q000009:adverse effects / Q000494:pharmacology*
chemical_list: D000732:Androstanols; D003473:Neuromuscular Nondepolarizing Agents; D010277:Parasympathomimetics; D047408:gamma-Cyclodextrins; D000077122:Sugammadex; D009388:Neostigmine; D000077123:Rocuronium
keywords: Caucasian; Chinese; Neostigmine; Neuromuscular blockade; Rocuronium; Sugammadex