Zhou Biyun, Li Shiyong, Luo Ailin, Zheng Hongbo
Department of Anesthesiology and Pain Medicine, Hubei Key Laboratory of Geriatric Anesthesia and Perioperative Brain Health, and Wuhan Clinical Research Center for Geriatric Anesthesia, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Heliyon. 2024 Sep 24;10(19):e38349. doi: 10.1016/j.heliyon.2024.e38349. eCollection 2024 Oct 15.
Although remimazolam tosilate is an ultra-short-acting benzodiazepine that causes less respiratory and circulatory depression than propofol, studies evaluating its efficacy and safety during endoscopic retrograde cholangiopancreatography (ERCP) are limited. This study aimed to compare the efficacy and safety of remimazolam and propofol for ERCP performed under monitored anesthesia care (MAC).
This study is a randomized controlled clinical trial featuring a noninferiority design. A total of 102 eligible patients undergoing ERCP under MAC were randomly assigned to either the remimazolam tosilate group (R group) or the propofol group (P group) in a 1:1 ratio. Patients in the R group were sedated with remimazolam tosilate, while those in the P group received propofol, both under MAC. The primary efficacy endpoint was the success rate of ERCP completion under MAC. Secondary outcomes included the time to loss of consciousness, sedative effects, and perioperative adverse events at various time points for patients in both groups.
Baseline characteristics of both groups were similar. The successful completion rate for ERCP under MAC was 100 % in the R group and 96.1 % in the P group, resulting in a difference of 3.92 % (95 % CI: -2%, 10 %). This difference met the pre-established criterion of being greater than -8%. The total number of norepinephrine infusions, as well as the incidence of intravenous injection pain, post-induction hypotension, post-induction bradycardia, intraoperative hypotension, respiratory depression, and hypoxemia, were significantly lower in the R group compared to the P group. Conversely, the total number of phloroglucinol uses, body movements, and instances of rapid gastrointestinal peristalsis were significantly higher in the R group than in the P group.
Remimazolam-based MAC for ERCP exhibited non-inferior efficacy compared to propofol-based MAC, while also resulting in fewer circulatory and respiratory adverse events during the procedures. Nevertheless, future studies with larger sample sizes are required to evaluate the utility of remimazolam in elderly patients.
尽管苯磺酸瑞马唑仑是一种超短效苯二氮䓬类药物，与丙泊酚相比，其引起的呼吸和循环抑制较轻，但评估其在内镜逆行胰胆管造影术（ERCP）期间疗效和安全性的研究有限。本研究旨在比较苯磺酸瑞马唑仑和丙泊酚在监护麻醉（MAC）下用于ERCP的疗效和安全性。
本研究是一项采用非劣效性设计的随机对照临床试验。总共102例在MAC下接受ERCP的符合条件的患者以1:1的比例随机分配到苯磺酸瑞马唑仑组（R组）或丙泊酚组（P组）。R组患者使用苯磺酸瑞马唑仑镇静，而P组患者在MAC下接受丙泊酚治疗。主要疗效终点是MAC下ERCP完成的成功率。次要结局包括两组患者在不同时间点的意识消失时间、镇静效果和围手术期不良事件。
两组的基线特征相似。R组MAC下ERCP的成功完成率为100%，P组为96.1%，差异为3.92%（95%CI：-2%，10%）。该差异符合预先设定的大于-8%的标准。与P组相比，R组去甲肾上腺素输注总量以及静脉注射疼痛、诱导后低血压、诱导后心动过缓、术中低血压、呼吸抑制和低氧血症的发生率显著更低。相反，R组间苯三酚使用总量、身体移动和胃肠道快速蠕动的发生率显著高于P组。
与丙泊酚为基础的MAC相比，苯磺酸瑞马唑仑为基础的MAC用于ERCP显示出非劣效性疗效，同时在手术过程中导致的循环和呼吸不良事件也更少。然而，需要更大样本量的未来研究来评估苯磺酸瑞马唑仑在老年患者中的效用。
