Sugammadex efficacy for reversal of rocuronium- and vecuronium-induced neuromuscular blockade: A pooled analysis of 26 studies

Study objective: To summarize and compare efficacy of sugammadex with neostigmine or placebo for reversal of rocuronium- or vecuronium-induced neuromuscular blockade (NMB), and to demonstrate consistency of sugammadex results across various patient populations. Design: Pooled analysis on data from 26 multicenter, randomized, Phase II and III studies. Setting: Operating room. Patients: 1855 adults undergoing surgery under general anesthesia and receiving rocuronium or vecuronium for NMB. Interventions: Sugammadex (2.0 mg/kg at second twitch reappearance [T-2; moderate NMB], 4.0 mg/kg at 1-2 post-tetanic counts [PTC; deep NMB] or 16.0 mg/kg at 3 min after rocuronium 12 mg/kg), neostigmine or placebo. Measurements: Time to recovery of the train-of -four(TOF) ratio to 0.9. Main results: Geometric mean (95% CI) times to recovery to TOF ratio of 0.9 were 1.9 (1.8-2.0) min following sugammadex 2.0 mg/kg and 10.6 (9.8-11.6) min following neostigmine administration at T2 after rocuronium, and 2.9 (2.5-3.4) min and 17.4 (13.4-22.6) min, respectively, after vecuronium. Recovery times were 2.2 (2.1-23) min following sugammadex 4.0 mg/kg and 19.0 (14.8-24.6) min following neostigmine administered at a target of 1-2 PTC after rocuronium, and 3.8 (3.0-5.0) min and 67.6 (563-812) min after vecuronium. Sugammadex administered 3 min after rocuronium 1.2 mg/kg resulted in rapid recovery (1.7 [1.5-2.0] min). Modest increases in mean recovery time were associated with vecuronium use (+1.6 min [78%; (61%-98%)] versus rocuronium), mild to-moderate renal impairment (+0.4 min [20%; (9%-32%)] versus normal renal function) and geographic location (+1.0 min [38%; (25%-52%)] in subjects in USA/Canada versus Europe/japan). Conclusions: Sugammadex administered at recommended doses provides rapid and predictable reversal of rocuronium and vecuronium-induced moderate and deep NMB, and effective reversal 3 min after rocuronium 1.2 mg/kg. Robust recovery was seen across various patient factors, providing further confirmation of labeled dose recommendations. (C) 2017 Elsevier Inc. All rights reserved.