Sugammadex 4.0 mg kg-1 Reversal of Deep Rocuronium-Induced Neuromuscular Blockade: A Multicenter Study in Chinese and Caucasian Patients
- *Corresponding Author:
- Professor Buwei Yu
Department of Anesthesiology
Ruijin Hospital, Shanghai Jiaotong University Medical School
197 Ruijin Er Road, Shanghai 200025, China
E-mail: [email protected]
Received Date: April 02, 2014; Accepted Date: May 21, 2014; Published Date: May 23, 2014
Citation: Yu B, Wang X, Helbo-Hansen HS, Huang WQ, Askeland B, et al. (2014) Sugammadex 4.0 mg kg–1 Reversal of Deep Rocuronium-Induced Neuromuscular Blockade: A Multicenter Study in Chinese and Caucasian Patients. J Anesth Clin Res 5:408. doi: 10.4172/2155-6148.1000408
Copyright: © 2014 Yu B, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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.