Zhao Li, Zhou Xuelei, Chen Linlin, Mao Wei, Guo Yiping, Liu Xianchun, Zhang Longyi, Xie Ying, Li Linji
Department of Anesthesiology, The Second Clinical Medical College, North Sichuan Medical College, Beijing Anzhen Nanchong Hospital of Capital Medical University & Nanchong Central Hospital, Nanchong, China.
Nanchong Center for Disease Control and Prevention, Nanchong, China.
Sci Rep. 2025 Apr 14;15(1):12770. doi: 10.1038/s41598-025-97649-1.
Remimazolam is a novel benzodiazepine sedative that provides effective sedation, stable haemodynamics, and minimal adverse effects during intravenous general anaesthesia. The aim of this study was to determine the 50% effective dose (ED50) of remimazolam combined with different doses of esketamine for painless gastroscopy and to evaluate the efficacy and safety of this combination.
This was a randomised, double-blind, up-and-down sequential allocation study. Patients undergoing painless gastroscopy who met all the inclusion criteria and did not meet any of the exclusion criteria were randomised in a 1:1:1 ratio into the ES0 group (0 mg/kg of esketamine), ES1 group (0.2 mg/kg of esketamine), and ES2 group (0.4 mg/kg of esketamine). The initial dose of remimazolam was 0.3 mg/kg in each group, with the dose increased or decreased by 0.05 mg/kg for the subsequent patient based on the success or failure of sedation in the previous patient. The trial was concluded when seven successful failure crossovers were achieved. The ED50 and 95% confidence intervals (CI) of remimazolam were calculated using Probit regression. Haemodynamic parameters, time to induction of anaesthesia, time to gastroscopy, time to awakening from anaesthesia, and adverse events were recorded.
A total of 59 patients were included in the final analysis: 19 in the ES0 group, 23 in the ES1 group, and 17 in the ES2 group. The ED50 (95% CI) of remimazolam in the ES0, ES1, and ES2 groups was 0.344 (0.302-0.389) mg/kg, 0.289 (0.249-0.328) mg/kg, and 0.193 (0.145-0.239) mg/kg, respectively. Additionally, the ES1 and ES2 groups exhibited more stable haemodynamics compared to the ES0 group. However, the ES1 and ES2 groups had significantly longer recovery times than the ES0 group. The incidence of hypotension was higher in the ES0 group compared to the ES1 and ES2 groups.
The ED50 of remimazolam combined with 0 mg/kg, 0.2 mg/kg, and 0.4 mg/kg of esketamine for induction of anaesthesia during painless gastroscopy was 0.344 mg/kg, 0.289 mg/kg, and 0.193 mg/kg, respectively. Combining esketamine with remimazolam for induction of anaesthesia during painless gastroscopy offers advantages in terms of haemodynamic stability and reduced adverse effects.
瑞马唑仑是一种新型苯二氮䓬类镇静剂，在静脉全身麻醉期间可提供有效的镇静效果、稳定的血流动力学和最小的不良反应。本研究的目的是确定瑞马唑仑联合不同剂量艾司氯胺酮用于无痛胃镜检查的半数有效剂量（ED50），并评估该联合用药的有效性和安全性。
这是一项随机、双盲、序贯分配研究。符合所有纳入标准且不符合任何排除标准的无痛胃镜检查患者按1:1:1的比例随机分为ES0组（0mg/kg艾司氯胺酮）、ES1组（0.2mg/kg艾司氯胺酮）和ES2组（0.4mg/kg艾司氯胺酮）。每组瑞马唑仑的初始剂量为0.3mg/kg，根据前一位患者镇静的成功或失败，后续患者的剂量增加或减少0.05mg/kg。当达到7次成功/失败交叉时试验结束。使用概率回归计算瑞马唑仑的ED50和95%置信区间（CI）。记录血流动力学参数、麻醉诱导时间、胃镜检查时间、麻醉苏醒时间和不良事件。
共有59例患者纳入最终分析：ES0组19例，ES1组23例，ES2组17例。ES0组、ES1组和ES2组瑞马唑仑的ED50（95%CI）分别为0.344（0.302 - 0.389）mg/kg、0.289（0.249 - 0.328）mg/kg和0.193（0.145 - 0.239）mg/kg。此外，与ES0组相比，ES1组和ES组的血流动力学更稳定。然而，ES1组和ES2组的恢复时间明显长于ES0组。ES0组低血压的发生率高于ES1组和ES2组。
瑞马唑仑联合0mg/kg、0.2mg/kg和0.4mg/kg艾司氯胺酮用于无痛胃镜检查麻醉诱导的ED50分别为0.344mg/kg、0.289mg/kg和0.193mg/kg。在无痛胃镜检查麻醉诱导中，艾司氯胺酮与瑞马唑仑联合使用在血流动力学稳定性和减少不良反应方面具有优势。
