Choe Jung Wan, Chung Moon Jae, Park Se Woo, Oh Dongwook, Han Sung Yong, Yang Min Jae, Kim Eui Joo, Cho Jae Hee, Lee Kyong Joo, Jang Sung Ill
Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.
Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Gastrointest Endosc. 2024 Aug;100(2):183-191.e1. doi: 10.1016/j.gie.2024.04.001. Epub 2024 Apr 3.
Propofol, a widely used sedative in GI endoscopic procedures, is associated with cardiorespiratory suppression. Remimazolam is a novel ultrashort-acting benzodiazepine sedative with rapid onset and minimal cardiorespiratory depression. This study compared the safety and efficacy of remimazolam and propofol during EUS procedures.
A multicenter randomized controlled study was conducted between October 2022 and March 2023 in patients who underwent EUS procedures. Patients were randomly assigned to receive either remimazolam or propofol as a sedative agent. The primary endpoint was cardiorespiratory adverse events (AEs) during the procedure, including desaturation, respiratory depression, hypotension, and tachycardia. Secondary endpoints were the time to achieve sedation, recovery time, quality of sedation, pain at the injection site, and satisfaction of both endoscopists and patients.
Four hundred patients enrolled in the study: 200 received remimazolam (10.8 ± 7.7 mg) and 200 received propofol (88.0 ± 49.1 mg). For cardiorespiratory AEs, the remimazolam group experienced fewer occurrences than the propofol group (8.5% vs 16%, P = .022). A nonsignificant trend was found toward less oxygen desaturation (1.0% vs 3.5%, P = .09), respiratory depression (.5% vs 1.5%, P = .62), hypotension (2.5% vs 5.5%, P = .12), and tachycardia (4.5% vs 5.5%, P = .68) with remimazolam than with propofol. Remimazolam showed a shorter induction time than propofol while maintaining comparable awakening and recovery times. Injection site pain was significantly lower in the remimazolam group than in the propofol group. The remimazolam group demonstrated a significantly higher quality of sedation and satisfaction scores than the propofol group, as evaluated by both endoscopists and patients.
Remimazolam was superior to propofol in terms of safety and efficacy during EUS examinations. (Clinical trial registration number: KCT 0007643.).
丙泊酚是胃肠内镜检查中广泛使用的镇静剂，与心肺抑制有关。瑞马唑仑是一种新型超短效苯二氮䓬类镇静剂，起效迅速，心肺抑制作用最小。本研究比较了瑞马唑仑和丙泊酚在超声内镜检查（EUS）过程中的安全性和有效性。
2022年10月至2023年3月，对接受EUS检查的患者进行了一项多中心随机对照研究。患者被随机分配接受瑞马唑仑或丙泊酚作为镇静剂。主要终点是检查过程中的心肺不良事件（AE），包括血氧饱和度降低、呼吸抑制、低血压和心动过速。次要终点是达到镇静的时间、恢复时间、镇静质量、注射部位疼痛以及内镜医师和患者的满意度。
400名患者纳入研究：200名接受瑞马唑仑（10.8±7.7mg），200名接受丙泊酚（88.0±49.1mg）。在心肺不良事件方面，瑞马唑仑组的发生率低于丙泊酚组（8.5%对16%，P = 0.022）。与丙泊酚相比，瑞马唑仑在氧饱和度降低（1.0%对3.5%，P = 0.09）、呼吸抑制（0.5%对1.5%，P = 0.62）、低血压（2.5%对5.5%，P = 0.12）和心动过速（4.5%对5.5%，P = 0.68）方面有减少趋势，但差异无统计学意义。瑞马唑仑的诱导时间比丙泊酚短，同时苏醒和恢复时间相当。瑞马唑仑组的注射部位疼痛明显低于丙泊酚组。内镜医师和患者评估显示，瑞马唑仑组的镇静质量和满意度评分明显高于丙泊酚组。
在EUS检查中，瑞马唑仑在安全性和有效性方面优于丙泊酚。（临床试验注册号：KCT 0007643。）
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