Abstract
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 [T2; 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 1.2 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 (2.1–2.3) 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 (56.3–81.2) 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.
| Original language | English |
|---|---|
| Pages (from-to) | 84-91 |
| Number of pages | 8 |
| Journal | Journal of Clinical Anesthesia |
| Volume | 41 |
| DOIs | |
| State | Published - Sep 2017 |
Keywords
- Neuromuscular blockade
- Neuromuscular blockade reversal
- Pooled analysis
- Sugammadex
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