Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points -: An international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial
Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points -: An international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial
复制标题
DOI：
10.1097/aln.0b013e31817f5bc7
复制
发表时间：
2008-08-01
期刊：
影响因子：
8.8
通讯作者：
Khuenl-Brady, Karin S.
中科院分区：
文献类型：
--
作者：
Puehringer, Friedrich K.;Rex, Christopher;Khuenl-Brady, Karin S.
背景：Sugammadex (Org 25969) 是一种新型选择性松弛剂结合剂，专门用于快速逆转罗库溴铵诱导的神经肌肉阻滞。评估了舒更葡糖逆转大剂量罗库溴铵引起的深度神经肌肉阻滞的有效性和安全性。方法：总共 176 名成年患者被随机分配，在丙泊酚期间大剂量罗库溴铵（1.0 或 1.2 mg/kg）后 3 或 15 分钟接受舒更葡糖（2、4、8、12 或 16 mg/kg）或安慰剂。麻醉。主要终点是将四人组比率恢复至 0.9 的时间。使用肌加速描记法进行神经肌肉监测。 结果：注射 1 mg/kg 罗库溴铵 3 或 15 分钟后给予舒更葡糖，以剂量依赖性方式将四联比中位恢复时间降低至 0.9，分别从 111.1 分钟和 91.0 分钟（安慰剂）降至 1.6 分钟和 0.9 分钟（16 mg/kg 舒更葡糖）。 1.2 mg/kg 罗库溴铵后，舒更葡糖将四连组恢复时间从 124.3 分钟（3 分钟组）和 94.2 分钟（15 分钟组）分别缩短至 1.3 分钟和 1.9 分钟（16 mg/kg 舒更葡糖）。没有临床证据表明神经肌肉阻滞复发或残留神经肌肉阻滞。探索性分析显示，一名患者出现了被认为可能与舒更葡糖有关的校正 QT 间期延长。另外两名患者在持续约 15 分钟的舒更葡糖治疗后出现明显的动脉血压异常。 结论：舒更葡糖苷可快速且剂量依赖性地逆转成人手术患者由高剂量罗库溴铵（1.0 或 1.2 mg/kg）引起的深度神经肌肉阻滞。
Background: Sugammadex (Org 25969), a novel, selective relaxant binding agent, was specifically designed to rapidly reverse rocuronium-induced neuromuscular blockade. The efficacy and safety of sugammadex for the reversal of profound, high-dose rocuronium-induced neuromuscular blockade was evaluated.Methods: A total of 176 adult patients were randomly assigned to receive sugammadex (2, 4, 8, 12, or 16 mg/kg) or placebo at 3 or 15 min after high-dose rocuronium (1.0 or 1.2 mg/kg) during propofol anesthesia. The primary endpoint was time to recovery of the train-of-four ratio to 0.9. Neuromuscular monitoring was performed using acceleromyography.Results: Sugammadex administered 3 or 15 min after injection of 1 mg/kg rocuronium decreased the median recovery time of the train-of-four ratio to 0.9 in a dose-dependent manner from 111.1 min and 91.0 min (placebo) to 1.6 min and 0.9 min (16 mg/kg sugammadex), respectively. After 1.2 mg/kg rocuronium, sugammadex decreased time to recovery of train-of-four from 124.3 min (3-min group) and 94.2 min (15-min group) to 1.3 min and 1.9 min with 16 mg/kg sugammadex, respectively. There was no clinical evidence of reoccurrence of neuromuscular blockade or residual neuromuscular blockade. Exploratory analysis revealed that prolongation of the corrected QT interval considered as possibly related to sugammadex occurred in one patient. Another two patients developed markedly abnormal arterial blood pressure after sugammadex that lasted approximately 15 min.Conclusion: Sugammadex provides a rapid and dose-dependent reversal of profound neuromuscular blockade induced by high-dose rocuronium (1.0 or 1.2 mg/kg) in adult surgical patients.