Rocuronium blockade reversal with sugammadex vs. neostigmine: randomized study in Chinese and Caucasian subjects

Xinmin Wu, Helle Oerding, Jin Liu, Bernard Vanacker, Shanglong Yao, Vegard Dahl, Lize Xiong, Casper Claudius, Yun Yue, Yuguang Huang, Esther Abels, Henk Rietbergen, Tiffany Woo, Xinmin Wu, Helle Oerding, Jin Liu, Bernard Vanacker, Shanglong Yao, Vegard Dahl, Lize Xiong, Casper Claudius, Yun Yue, Yuguang Huang, Esther Abels, Henk Rietbergen, Tiffany Woo

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.

Conclusion: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT00825812.

Keywords: Caucasian; Chinese; Neostigmine; Neuromuscular blockade; Rocuronium; Sugammadex.

Figures

Figure 1
Figure 1
Patient disposition and flow through the study (in accordance with CONSORT guidelines). FAS: full analysis set.
Figure 2
Figure 2
Time from start of administration of sugammadex or neostigmine to recovery of the train-of-four (TOF) ratio to 0.9 in Chinese and Caucasian subjects (full analysis set).
Figure 3
Figure 3
Cumulative percentage of Chinese and Caucasian subjects recovering to a train-of-four (TOF) ratio of 0.9 over time (full analysis set).

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Source: PubMed

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