Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial
Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial
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DOI：
10.1007/s00540-020-02788-6
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发表时间：
2020-05-16
影响因子：
2.8
通讯作者：
Suzuki, Toshiyasu
中科院分区：
文献类型：
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作者：
Doi, Matsuyuki;Morita, Kiyoshi;Suzuki, Toshiyasu
目的本试验旨在证实瑞咪唑仑与异丙酚在手术患者全身麻醉诱导和维持中的非劣效性。方法375例外科手术患者随机分为瑞咪唑仑6 mg/kg/h或12 mg/kg/h持续静脉滴注至意识消失(LoC)，然后适当调整1 mg/kg/h至手术结束，或缓慢静脉注射异丙酚2.0~2.5 mg/kg至LoC，然后静注4~10 mg/kg至手术结束。疗效是通过不需要术中苏醒/回忆、不需要抢救性镇静剂和没有身体运动的综合主要终点来衡量的。安全性监测不良事件和药物不良反应(ADRs)。结果所有治疗组的有效率均为100%，且瑞咪唑仑的疗效不逊色[95%可信区间(-0.0487；0.0250)]。瑞咪唑仑6组(p<；0.0001)和12 mg/kg/h组(p=0.0149)与异丙酚组相比，达到下限时间更长。瑞咪唑仑组拔管时间均长于异丙酚组(p
Purpose This trial was conducted to confirm the non-inferiority of remimazolam versus propofol in the induction and maintenance of general anesthesia in surgical patients. Methods Surgical patients (n = 375) were randomized to remimazolam started at 6 or 12 mg/kg/h by continuous intravenous (IV) infusion until the loss of consciousness (LoC), followed by 1 mg/kg/h to be adjusted as appropriate until the end of surgery or IV propofol administered as a slow bolus of 2.0-2.5 mg/kg until LoC followed by 4-10 mg/kg/h until the end of surgery. Efficacy was measured via the combined primary endpoint of no intraoperative awakening/recall, no need for rescue sedatives, and no body movements. Adverse events and adverse drug reactions (ADRs) were monitored for safety. Results Efficacy rates were 100% in all treatment groups, and the non-inferiority of remimazolam was demonstrated [95% confidence interval (- 0.0487; 0.0250)]. The time to LoC was longer in the remimazolam 6 (p < 0.0001) and 12 mg/kg/h (p = 0.0149) groups versus propofol. The time to extubation was longer in both remimazolam groups versus the propofol group (p