Анестезия и клинические исследования
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ISSN: 2155-6148
ISSN: 2155-6148
Buwei Yu, Xiangrui Wang, Hans S Helbo-Hansen, Wen-Qi Huang, Bjarte Askeland, Shitong Li, Zhengnian Ding, Esther Abels, Henk Rietbergen, Tiffany Woo and Philippe Pendeville
Objective: Maintenance of deep Neuro Muscular Blockade (NMB) until the end of surgery may be beneficial in some surgical procedures. The selective relaxant binding agent sugammadex rapidly reverses deep levels of rocuronium-induced NMB. The purpose of this study was to evaluate the efficacy and safety of sugammadex 4.0 mg kg–1 for reversal of deep rocuronium-induced NMB in Chinese and Caucasian patients.
Methods: This was an open-label, multicenter, prospective Phase III efficacy study in adult American Society of Anesthesiologists Class 1-3 patients scheduled for surgery under general anesthesia and requiring deep NMB. All patients received intravenous propofol and opioids for induction and maintenance of anesthesia, and a single intubation dose of rocuronium 0.6 mg/kg, with maintenance doses of 0.1-0.2 mg/kg as required. Sugammadex 4.0 mg/kg was administered after the last dose of rocuronium, at a target blockade depth of 1-2 post-tetanic counts. The primary efficacy endpoint was time from sugammadex administration to recovery of the train-of-four (TOF) ratio to 0.9. Safety was also evaluated.
Results: Overall, 115 Chinese and 36 Caucasian patients were treated. Geometric mean (95% confidence interval) times to recovery of the TOF ratio to 0.9 were 2.3 (2.1 to 2.6) minutes and 1.4 (1.3 to 1.6) minutes in Chinese and Caucasian patients, respectively. Adverse events were reported in 57% of Chinese patients and 64% of Caucasian patients.
Conclusion: This study demonstrates that sugammadex 4.0 mg kg–1 provides effective and rapid reversal of deep rocuronium-induced NMB in Chinese and Caucasian patients. Efficacy equivalence between the two populations cannot be claimed.