Rocuronium blockade reversal with sugammadex vs. neostigmine: randomized study in Chinese and Caucasian subjects
1 Peking University First Hospital, No 8 Xishiku St, Beijing 100034, China
2 Department of Anaesthesiology, Vejle Hospital, Vejle, Denmark
3 West China Hospital, Sichuan University, Chengdu, China
4 Department of Anesthesiology, University Hospitals Leuven, Leuven, Belgium
5 Union Hospital, Tongji Medical College, Wuhan, China
6 Anaesthesia and Intensive Care, Asker and Baerum Hospital, Oslo, Norway
7 Department of Anesthesiology, Xijing Hospital, The Fourth Military Medical University, Xi’an, China
8 Department of Anaesthesia, Hillerød Hospital, Hillerød, Denmark
9 Beijing Chaoyang Hospital, Beijing, China
10 Peking Union Medical College Hospital, Beijing, China
11 MSD, Oss, The Netherlands
12 Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA
BMC Anesthesiology 2014, 14:53 doi:10.1186/1471-2253-14-53Published: 12 July 2014
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT00825812.