Klinik für Anästhesiologie und Operative Intensivmedizin, Klinikum am Steinenberg, Reutlingen, Germany.
Br J Anaesth. 2010 Nov;105(5):610-9. doi: 10.1093/bja/aeq226. Epub 2010 Sep 28.
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 T₄/T₁ 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 T₄/T₁ 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.
在丙泊酚麻醉中，舒更葡糖显示出对神经肌肉阻滞（NMB）逆转的剂量反应关系。与丙泊酚不同，七氟醚可以延长神经肌肉阻滞药物（NMBAs）的作用，延长恢复时间。本开放性、随机、剂量发现试验旨在探索舒更葡糖在七氟醚维持麻醉中用于逆转中等罗库溴铵或维库溴铵诱导的 NMB 时的剂量反应关系、安全性和药代动力学。
在丙泊酚诱导麻醉后，成年患者被随机分为接受单剂量罗库溴铵 0.9mg/kg 或维库溴铵 0.1mg/kg，根据需要给予维持剂量。用七氟醚维持麻醉。使用加速肌电图监测 NMB。在最后一次 NMBA 剂量后，当 T₂再次出现时，给予单剂量舒更葡糖 0.5、1.0、2.0 或 4.0mg/kg 或安慰剂。主要疗效变量是从舒更葡糖给药开始到 T₄/T₁ 比值恢复到 0.9 的时间。整个过程中进行安全性评估。
符合方案人群包括 93 名患者（罗库溴铵，n=46；维库溴铵，n=47）。随着舒更葡糖剂量的增加，两种 NMBA 的 T₄/T₁ 比值恢复至 0.9 的平均恢复时间均显示出统计学显著的剂量反应关系：罗库溴铵，96.3min（安慰剂）至 1.5min（舒更葡糖 4.0mg/kg）；维库溴铵，79.0min（安慰剂）至 3.0min（舒更葡糖 4.0mg/kg）。舒更葡糖的血浆浓度表明药代动力学呈线性，与给予的 NMBA 无关。没有发生与研究药物相关的严重不良事件。7 名患者报告出现阻滞复发的证据[舒更葡糖 0.5mg/kg（剂量不足），n=6；2.0mg/kg，n=1]。
在七氟醚维持麻醉中，舒更葡糖可提供良好耐受、有效、剂量依赖性的中等罗库溴铵和维库溴铵诱导的 NMB 逆转。
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