Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship

被引:57
|
作者
Puehringer, F. K. [1 ]
Gordon, M. [2 ]
Demeyer, I. [3 ]
Sparr, H. J. [4 ]
Ingimarsson, J. [5 ]
Klarin, B. [6 ]
van Duijnhoven, W. [7 ]
Heeringa, M. [7 ]
机构
[1] Klinikum Steinenberg, Klin Anasthesiol & Operat Intens Med, D-72764 Reutlingen, Germany
[2] Samodzielny Publiczny Szpital Kliniczny 2, Poznan, Poland
[3] Onze Lieve Vrouw Hosp, Aalst, Belgium
[4] Gen Hosp, Dept Anesthesia & Intens Care Med, Dornbirn, Austria
[5] UMAS, Malmo, Sweden
[6] Univ Sjukhuset Lund, Lund, Sweden
[7] MSD, Oss, Netherlands
关键词
reversal; rocuronium; sevoflurane; sugammadex; vecuronium; RELAXANT BINDING-AGENT; MAINTENANCE ANESTHESIA; PHASE-II; MULTICENTER; ORG-25969; BROMIDE; SAFETY; DRUG; PHARMACOKINETICS; NEOSTIGMINE;
D O I
10.1093/bja/aeq226
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
Sugammadex shows a dose-response relationship for reversal of neuromuscular block (NMB) during propofol anaesthesia. Sevoflurane, unlike propofol, can prolong the effect of neuromuscular blocking agents (NMBAs), increasing recovery time. This open-label, randomized, dose-finding trial explored sugammadex dose-response relationships, safety, and pharmacokinetics when administered for reversal of moderate rocuronium- or vecuronium-induced NMB during sevoflurane maintenance anaesthesia. After anaesthesia induction with propofol, adult patients were randomized to receive single-dose rocuronium 0.9 mg kg(-1) or vecuronium 0.1 mg kg(-1), with maintenance doses as needed. Anaesthesia was maintained with sevoflurane. NMB was monitored using acceleromyography. After the last dose of NMBA, at reappearance of T(2), single-dose sugammadex 0.5, 1.0, 2.0, or 4.0 mg kg(-1) or placebo was administered. The primary efficacy variable was time from the start of sugammadex administration to recovery of T(4)/T(1) ratio to 0.9. Safety assessments were performed throughout. The per-protocol population comprised 93 patients (rocuronium, n=46; vecuronium, n=47). A statistically significant dose-response relationship was demonstrated for mean recovery times of T(4)/T(1) ratio to 0.9 with increasing sugammadex dose with both NMBAs: rocuronium, 96.3 min (placebo) to 1.5 min (sugammadex 4.0 mg kg(-1)); vecuronium, 79.0 min (placebo) to 3.0 min (sugammadex 4.0 mg kg(-1)). Plasma sugammadex concentrations indicated linear pharmacokinetics, independent of NMBA administered. No study drug-related serious adverse events occurred. Evidence of reoccurrence of block was reported in seven patients [sugammadex 0.5 mg kg(-1) (suboptimal dose), n=6; 2.0 mg kg(-1), n=1]. During sevoflurane maintenance anaesthesia, sugammadex provides well-tolerated, effective, dose-dependent reversal of moderate rocuronium- and vecuronium-induced NMB.
引用
收藏
页码:610 / 619
页数:10
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