【罂粟摘要】瑞马唑仑与丙泊酚在EUS中的安全性和有效性:一项多中心随机对照研究

文摘   2024-11-25 07:03   贵州  

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瑞马唑仑与丙泊酚在EUS中的安全性和有效性:

一项多中心随机对照研究


贵州医科大学  麻醉与心脏电生理课题组

翻译:文春雷  编辑:王婷婷  审校:曹莹

背景与目的:丙泊酚是一种广泛用于胃肠内镜手术的镇静剂,但与心肺抑制相关。瑞马唑仑是一种新型超短效苯二氮䓬类镇静剂,具有起效速度快和心肺抑制小的特点。本研究比较了瑞马唑仑和丙泊酚在内镜超声(EUS)手术中的安全性和有效性。


方法:在2022年10月至2023年3月期间,对接受EUS手术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。主要终点是手术期间的心肺不良事件(AE),包括低氧饱和、呼吸抑制、低血压和心动过速。次要终点包括达到镇静的时间、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。


结果:共有400名患者参与了研究:200名接受了瑞马唑仑(10.8 ± 7.7 mg),200名接受了丙泊酚(88.0 ± 49.1 mg)。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% vs 16%,P = .022)。在低氧饱和(1.0% vs 3.5%,P = .09)、呼吸抑制(0.5% vs 1.5%,P = .62)、低血压(2.5% vs 5.5%,P = .12)和心动过速(4.5% vs 5.5%,P = .68)方面,瑞马唑仑组也表现出非显著的趋势。瑞马唑仑的诱导时间短于丙泊酚,同时保持了相似的苏醒和恢复时间。瑞马唑仑组的注射部位疼痛明显低于丙泊酚组。瑞马唑仑组在镇静质量和满意度评分方面显著高于丙泊酚组,内镜医师和患者的评估结果一致。



结论:在EUS检查中,瑞马唑仑在安全性和有效性方面优于丙泊酚。

原始文献来源: Jung Wan Choe, Moon Jae Chung, Se Woo Park, et al. Safety and efficacy of remimazolam versus propofol during EUS: a multicenter randomized controlled study.[J]. Gastrointest Endosc, 2024, 100 (2): 183-191.


Safety and efficacy of remimazolam versus propofol during

EUS: a multicenter randomized controlled study


Background and Aims: 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.
Methods: 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.
Results: 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 Z .022). A nonsignificant trend was found toward less oxygen desaturation (1.0% vs 3.5%, P Z .09), respiratory depression (.5% vs 1.5%, P Z .62), hypotension (2.5% vs 5.5%, P Z .12), and tachycardia (4.5% vs 5.5%, P Z .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.
Conclusions: Remimazolam was superior to propofol in terms of safety and efficacy during EUS examinations.
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