甲苯磺酸瑞马唑仑与依托咪酯-丙泊酚在老年门诊结肠镜检查患者的疗效和安全性比较：一项前瞻性、随机、单盲、非劣效性试验

以下文章来源于罂粟花 ，作者anesthGH

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甲苯磺酸瑞马唑仑与依托咪酯-丙泊酚在老年门诊结肠镜检查患者的疗效和安全性比较：一项前瞻性、随机、单盲、非劣效性试验

贵州医科大学  麻醉与心脏电生理课题组

翻 译：胡廷菊

编 辑：柏雪

审 校：曹莹

背景：

合适的内镜麻醉镇静方案仍存在争议，尤其对于老年患者。在此项研究中，我们比较了甲苯磺酸瑞马唑仑（RT）和依托咪酯-丙泊酚（EP）用于门诊拟行肠镜的老年患者的有效性和安全性。

方法：

将260例接受结肠镜检查镇静的老年门诊患者随机分为两组。RT组患者接受瑞马唑仑初始剂量0.15mg/kg后，给予0.075mg/kg维持剂量，患者在EP组中（10ml：20mg依托咪酯+10ml：100mg丙泊酚）接受初始剂量0.1 ml/kg,以0.05ml/kg剂量维持，整个手术过程患者MOAA/S评分≤3。主要观察指标是手术成功率。次要观察指标包括时间、血流动力学、芬太尼、依托咪酯、丙泊酚和瑞马唑仑的消耗量、术中肢体运动、患者和内镜医生满意度评分、镇静剂和芬太尼的补加剂量以及不良事件的发生率和严重程度。

结果：

RT组的手术成功率为96.52%，EP组为100%。RT组和EP组之间的手术成功率差异为−3.48%（95%可信区间：−6.81%，−0.15%）。RT组中有4例患者需要补加咪达唑仑。与RT组患者相比，EP组的起效时间显著降低（p < 0.05），而EP组的完全警觉时间（p = 0.001）、准备离院时间（p = 0.001）和离院时间（p = 0.002）均显著高于EP组患者。但两组患者在手术时间（p = 0.846）和盲肠插管时间（p = 0.320）方面的差异均无统计学意义。虽然RT组术中体动频率较高，但差异无统计学意义（p = 0.508）。患者的人口统计学特征和基线特征、镇静剂和芬太尼补充剂量、患者和内镜医生满意度评分均无显著差异（p > 0.05）。EP组注射时肌肉震颤和注射痛的频率更高（p < 0.05）。然而，在缺氧、呼吸抑制、术后恶心和呕吐的发生率方面没有显著差异。两组患者不良事件的严重程度均为轻度（1级）。

结论：

RT对老年结肠镜检查的门诊患者的疗效可能不如EP，但安全性更高，提示RT可能更适合老年结肠镜检查的门诊患者。

原始文献来源：

Liu X, Ding B, Shi F, Zhang Y, Liu L, Sha Y, Zhao T. The Efficacy and Safety of Remimazolam Tosilate versus Etomidate-Propofol in Elderly Outpatients Undergoing Colonoscopy: A Prospective, Randomized, Single-Blind, Non-Inferiority Trial. Drug Des Devel Ther. 2021 Nov 16;15:4675-4685. doi: 10.2147/DDDT.S339535. PMID: 34819721; PMCID: PMC8606755.

英文原文：

The Efficacy and Safety of Remimazolam Tosilateversus Etomidate-Propofol in Elderly Outpatients Undergoing Colonoscopy: A Prospective, Randomized, Single-Blind, Non-Inferiority Trial

Abstract

Background:The optimal sedation regime during endoscopy remains controversial, especially for elderly outpatients. In this study, we compared the efficacy and safety between remimazolam tosilate (RT) and etomidate-propofol (EP) in elderly outpatients undergoing colonoscopy.

Methods: A total of 260 elderly outpatients undergoing sedative colonoscopy were randomized into two groups. Patients in the RT group received a 0.075mg/kg maintenance dose of remimazolam following an initial dose of 0.15 mg/kg, whereas patients in the EP group (10 ml:20 mg etomidate plus 10 ml:100 mg propofol) received a 0.05ml/kg maintenance dose following an initial dose of 0.1 ml/kg to maintain a Modified Observer’s Assessment of Alertness/Sedation score of ≤3 during the procedure. The primary endpoint was the success of the procedure. Secondary endpoints included time metrics, hemodynamics, consumption of fentanyl, etomidate, propofol, and remimazolam, intraoperative body movement, patient and endoscopist satisfaction scores, supplemental dose of sedative and fentanyl, and incidence and severity of adverse events.

Results: The procedure success rate was 96.52% in the RT group and 100% in the EP group. The difference in procedure success rate between the RT and EP groups was −3.48% (95% confidence interval: −6.81%, −0.15%). Four patients in the RT group required rescue midazolam. Compared with patients in the RT group, the onset time of the EP group was significantly lower (p < 0.05), whereas time to fully alert (p = 0.001), ready for discharge (p = 0.001), and hospital discharge (p = 0.002) were all significantly higher in the EP group.

However, there were no significant differences in procedure time (p = 0.846) or cecal intubation time (p = 0.320) between the two groups. Although the frequency of intraoperative body movement was higher in the RT group, the difference was not significant (p = 0.508). There were no significant differences in patients’ demographic and baseline characteristics, supplemental doses of sedative and fentanyl, or patient and endoscopist satisfaction scores (p > 0.05). Muscular tremor and pain on injection were recorded more frequently

in the EP group (p < 0.05). However, there were no significant differences in hypoxia, respiratory depression, or incidence of postoperative nausea and vomiting. The severity of adverse events was all mild (grade 1) across both groups.

Conclusions:RT may have non-inferior efficacy and a higher safety profile than EP in elderly outpatients undergoing colonoscopy, which suggests that RT may be more suitable for elderly outpatients undergoing colonoscopy.

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编辑：Michel.米萱

校对：MiLu.米鹭

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