Comparison of 95% effective dose of remimazolam besylate and propofol for gastroscopy sedation on older patients: A single-centre randomized controlled trial
Comparison of 95% effective dose of remimazolam besylate and propofol for gastroscopy sedation on older patients: A single-centre randomized controlled trial
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DOI：
10.1111/bcp.15839
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发表时间：
2023-07-20
影响因子：
3.4
通讯作者：
Fang，Xiangming
中科院分区：
文献类型：
--
作者：
Ye，Enci;Wu，Keyang;Fang，Xiangming
目的高龄是程序性镇静不良事件发生的重要危险因素。雷马唑仑用于胃镜镇静安全有效。然而，老年患者的理想剂量和应用尚不清楚。我们的目的是研究其在老年胃镜患者中的95%有效剂量（ED95），并以异丙酚为对照，评估其安全性和有效性。方法本试验分为2部分，选取年龄在50 ~ 65岁，计划门诊进行无痛胃镜检查的患者。在第一部分中，采用Dixon的上下法测定胃镜插入用苯磺酸雷马唑仑和异丙酚联合0.2 μg/kg瑞芬太尼的ED95。第二部分，各组患者分别给予0.2 μg/kg瑞芬太尼和ED95剂量的研究药物进行镇静诱导，必要时补充剂量维持镇静深度。主要结局是不良事件的发生率。次要观察指标为恢复时间。结果苯磺酸雷马唑仑和异丙酚诱导的ED95分别为0.2039(95%可信区间0.1753 ~ 0.3896)mg/kg和1.9733(95%可信区间1.7346 ~ 3.7021)mg/kg。雷马唑仑组26例（40.6%）报告不良事件，异丙酚组54例（83.1%）报告不良事件（P< 0.05）。0001)，而雷马唑仑组打嗝发生率更高（P= 0.0169）。与异丙酚组相比，雷马唑仑组唤醒的中位时间约短1 min （P< 0.05）。结论对于接受胃镜检查的老年患者，在诱导相同镇静深度时，ED95剂量的雷马唑仑比异丙酚更安全。
AimsAdvanced age is an important risk factor for adverse events during procedural sedation. Remimazolam is safe and effective in gastroscopic sedation. However, the ideal dose and application for older patients are not well known. We aim to investigate its 95% effective dose (ED95) for older patients undergoing gastroscopy and to assess its safety and efficacy, with propofol as the comparison.MethodsThe trial consists of 2 parts, patients aged >65 years and scheduled for outpatient painless gastroscopy were enrolled. In the first part, Dixon's up‐and‐down methodology was used to determine the ED95 of remimazolam besylate and propofol for gastroscopic insertion, in combination with 0.2 μg/kg remifentanil. In the second part, patients in each group received 0.2 μg/kg remifentanil and ED95 dose of the study drugs for sedation induction, supplemental doses were added to maintain sedation depth when necessary. The primary outcome was the incidence of adverse events. The secondary outcome was the recovery time.ResultsThe ED95 of remimazolam besylate and propofol induction were 0.2039 (95% confidence interval 0.1753–0.3896) mg/kg and 1.9733 (95% confidence interval 1.7346–3.7021) mg/kg respectively. Adverse events were reported in 26 (40.6%) patients in the remimazolam group and 54 (83.1%) in the propofol group (P< .0001), whereas the remimazolam group presented a higher incidence of hiccups (P= .0169). Besides, the median time to awakening was approximately 1 min shorter with remimazolam than with propofol (P< .05).ConclusionFor older patients undergoing gastroscopy, the ED95 dose of remimazolam is a safer alternative than propofol when inducing the same sedation depth.