首页> 外文期刊>American journal of therapeutics >Safety and Efficacy of Rocuronium With Sugammadex Reversal Versus Succinylcholine in Outpatient SurgeryA Multicenter, Randomized, Safety Assessor-Blinded Trial
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Safety and Efficacy of Rocuronium With Sugammadex Reversal Versus Succinylcholine in Outpatient SurgeryA Multicenter, Randomized, Safety Assessor-Blinded Trial

机译:Sugammadex逆转与琥珀酰胆碱在门诊手术中使用罗库溴铵的安全性和有效性一项多中心,随机,安全评估者盲试验

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摘要

Complex surgical procedures are increasingly performed in an outpatient setting, with emphasis on rapid recovery and case turnover. In this study, the combination of rocuronium for neuromuscular blockade (NMB) reversed by single-dose sugammadex was compared with succinylcholine followed by spontaneous recovery in outpatient surgery. This multicenter, randomized, safety assessor-blinded study enrolled adults undergoing a short elective outpatient surgical procedure requiring NMB and tracheal intubation. Patients were randomized to NMB with either rocuronium 0.6 mg/kg for tracheal intubation with incremental doses of rocuronium 0.15 mg/kg and subsequent reversal with sugammadex 4.0 mg/kg at 1-2 posttetanic counts or succinylcholine 1.0 mg/kg for intubation with spontaneous recovery. The primary efficacy end point was the time from sugammadex administration to recovery of the train-of-four ratio to 0.9; for succinylcholine, time from administration to recovery of the first twitch (T-1) to 90% was assessed. From 167 patients enrolled, 150 received treatment. The all-subjects-treated population comprised 70 patients in the rocuronium-sugammadex group and 80 in the succinylcholine group. Geometric mean (95% confidence interval) time from the start of sugammadex administration to recovery of the train-of-four ratio to 0.9 was 1.8 (1.6-2.0) minutes. Geometric mean (95% confidence interval) time from succinylcholine administration to recovery of T-1 to 90% was 10.8 (10.1-11.5) minutes. Health outcome variables were similar between the groups. Adverse events were reported in 87.1% and 93.8% of patients for rocuronium-sugammadex and succinylcholine, respectively. In conclusion, rocuronium for intubation followed by sugammadex for reversal of NMB offers a viable treatment option in outpatient surgery without prolonging recovery duration or jeopardizing safety.
机译:在门诊环境中,越来越多地执行复杂的外科手术,重点是快速恢复和病例更替。在这项研究中,将罗库溴铵与单剂量舒马葡糖逆转的神经肌肉阻滞(NMB)组合与琥珀酰胆碱进行比较,然后在门诊手术中自发恢复。这项多中心,随机,安全性评估者盲的研究招募了接受短期选择性门诊手术且需要NMB和气管插管的成年人。患者随机分为NMB组,用罗库溴铵0.6 mg / kg进行气管插管,增加剂量的罗库溴铵0.15 mg / kg,随后在1-2次强直性计数时逆转用舒美葡糖4.0 mg / kg逆转,或用琥珀酰胆碱1.0 mg / kg进行气管插管并自发恢复。主要功效终点是从给予舒马地葡糖到四链比率恢复到0.9的时间;对于琥珀酰胆碱,评估了从给药到第一次抽搐(T-1)恢复到90%的时间。在167名患者中,有150名接受了治疗。全受试者治疗的人群包括罗库溴铵-sugammadex组的70名患者和琥珀酰胆碱组的80名患者。从开始添加sugammadex到四链比率恢复到0.9的几何平均时间(95%置信区间)为1.8(1.6-2.0)分钟。从服用琥珀酰胆碱到T-1恢复至90%的几何平均时间(95%置信区间)为10.8(10.1-11.5)分钟。两组之间的健康结果变量相似。罗库溴铵-sugammadex和琥珀酰胆碱的不良事件分别报道在87.1%和93.8%的患者中。总而言之,罗库溴铵用于插管,然后舒马地葡糖用于NMB的逆转在门诊手术中提供了可行的治疗选择,而不会延长恢复时间或危及安全性。

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