Li Dongbin, Wang Yu, Xing Yang, Zhao Zicen, Chang Liya, Leng Yufang
The First Clinical Medical College of Lanzhou University, Lanzhou, 730000, GanSu Province, China.
The Department of Anaesthesiology, The First Hospital of Lanzhou University, Lanzhou, 730000, GanSu Province, China.
Int J Clin Pharm. 2024 Dec;46(6):1371-1380. doi: 10.1007/s11096-024-01774-2. Epub 2024 Jul 31.
Remimazolam tosilate is a new type of benzodiazepine currently used for gastrointestinal endoscopy and can be combined with alfentanil.
This trial compared the effectiveness and safety of remimazolam with alfentanil to propofol with alfentanil in patients undergoing gastrointestinal endoscopy.
One hundred and sixty-six patients were randomly divided into propofol-alfentanil anaesthesia (Group P) and remimazolam-alfentanil anaesthesia (Group R). The primary outcomes were perioperative haemodynamic variables, including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR) and oxygen saturation (SpO) preoperatively (T0); after anaesthesia induction (T1); when the gastroscope passed through the oropharynx (T2); 3 min (T3), 5 min (T4) and 7 min (T5) after T2; at the end of surgery (T6); and when patients successfully awakened (T7). The secondary outcomes included induction and awakening time, patient satisfaction, operator satisfaction, and adverse event occurrences.
Compared with those in Group P, the SBP in Group R was significantly higher at T1, T2, T3, and T6 (P < 0.05); the DBP and MAP were significantly higher at T1, T2, T3, T5, and T6 (P < 0.05); the HR was significantly faster at T1 to T6 (P < 0.05); the SpO was significantly higher at T1 to T4 (P < 0.05); the incidences of hypoxemia, hypotension, and drug injection pain were significantly lower in Group R (P < 0.05); the incidence of hiccups was higher (P < 0.05); the awakening time was shorter in Group R (P < 0.05); and the operator satisfaction score was high (P < 0.05).
Compared to propofol with alfentanil, remimazolam with alfentanil can be used safely and effectively for sedation in patients undergoing gastrointestinal endoscopy, with less impact on the patient's circulatory and respiratory systems and a lower incidence of adverse events.
This trial protocol was registered in the Chinese Clinical Trial Registry (ChiCR2300077252, date: 2023-11-02).
甲苯磺酸瑞马唑仑是一种新型苯二氮䓬类药物，目前用于胃肠内镜检查，可与阿芬太尼联合使用。
本试验比较了甲苯磺酸瑞马唑仑联合阿芬太尼与丙泊酚联合阿芬太尼用于胃肠内镜检查患者的有效性和安全性。
166例患者随机分为丙泊酚-阿芬太尼麻醉组（P组）和甲苯磺酸瑞马唑仑-阿芬太尼麻醉组（R组）。主要观察指标为围手术期血流动力学变量，包括术前（T0）、麻醉诱导后（T1）、胃镜通过口咽部时（T2）、T2后3分钟（T3）、5分钟（T4）和7分钟（T5）、手术结束时（T6）以及患者成功苏醒时（T7）的收缩压（SBP）、舒张压（DBP）、平均动脉压（MAP）、心率（HR）和血氧饱和度（SpO）。次要观察指标包括诱导和苏醒时间、患者满意度、术者满意度及不良事件发生率。
与P组相比，R组在T1、T2、T3和T6时SBP显著升高（P<0.05）；在T1、T2、T3、T5和T6时DBP和MAP显著升高（P<0.05）；在T1至T6时HR显著增快（P<0.05）；在T1至T4时SpO显著升高（P<0.05）；R组低氧血症、低血压和药物注射痛的发生率显著降低（P<0.05）；呃逆发生率较高（P<0.05）；R组苏醒时间较短（P<0.05）；术者满意度评分较高（P<0.05）。
与丙泊酚联合阿芬太尼相比，甲苯磺酸瑞马唑仑联合阿芬太尼可安全有效地用于胃肠内镜检查患者的镇静，对患者循环和呼吸系统影响较小，不良事件发生率较低。
本试验方案已在中国临床试验注册中心注册（ChiCR2300077252，日期：2023年11月2日）。
