Armbrecht Andrea C, Kovacevic Bojan, Rasmussen Maria Dyrehave, Bernth Michelle Katharina, Moeller Ann Merete, Vilmann Peter
Herlev, Herlev Hospital, Herlev, Denmark.
Antioquia, Universidad de Antioquia, Medellin, Colombia.
Endosc Int Open. 2025 Aug 15;13:a26551083. doi: 10.1055/a-2655-1083. eCollection 2025.
Remimazolam is a new ultra-short-acting benzodiazepine with a favorable safety-profile when used for sedation in endoscopy. The aim of this project was to investigate efficacy of remimazolam with fentanyl compared with midazolam with fentanyl for sedation in colonoscopy among fecal immunochemical test (FIT)-positive screening participants.
The study was a prospective, single-blinded, randomized controlled trial. FIT-positive participants undergoing colonoscopy were randomized to intravenous remimazolam + fentanyl (RF) or midazolam + fentanyl (MF). Primary outcome was total time from start of medication until discharge. Secondary outcomes included time to reach cecum, need for post-procedure recovery, patient-reported pain and satisfaction, need for additional medication, and procedure completion.
A total of 205 patients were included and randomized 1:1 (RF:103, MF:102). Mean age was 62.6 years, whereas female/male ratio was 97/108. Mean time from start of medication until discharge was 29.9 minutes (RF) versus 35.0 minutes (MF) (95% confidence interval 0.77-0.94, = 0.012). Mean time to reach the cecum was 15.4 minutes (RF) compared with 20.2 minutes (MF) ( = 0.001). Proportion of patients requiring postoperative observation was lower for RF 0.97% vs 9.8% for MF ( = 0.022). Patients receiving remimazolam reported an average lower pain score (mean 2.25 (RF) vs 3.25 (MF) = 0.012) and higher overall satisfaction score (4.65 vs 4.33, = 0.012).
This study shows clear superiority of the combination of remimazolam with fentanyl over midazolam with fentanyl for conscious sedation in screening colonoscopy, obtaining shorter procedure time, less postoperative need for observation, lower patient pain scores, and higher patient satisfaction.
瑞马唑仑是一种新型超短效苯二氮䓬类药物，在内镜检查镇静中使用时具有良好的安全性。本项目旨在研究在粪便免疫化学试验（FIT）阳性的结肠镜检查筛查参与者中，瑞马唑仑联合芬太尼与咪达唑仑联合芬太尼用于镇静的疗效。
本研究为前瞻性、单盲、随机对照试验。接受结肠镜检查的FIT阳性参与者被随机分为静脉注射瑞马唑仑+芬太尼（RF）组或咪达唑仑+芬太尼（MF）组。主要结局是从开始用药到出院的总时间。次要结局包括到达盲肠的时间、术后恢复的需求、患者报告的疼痛和满意度、额外用药的需求以及检查完成情况。
共纳入205例患者并按1:1随机分组（RF组103例，MF组102例）。平均年龄为62.6岁，女性/男性比例为97/108。从开始用药到出院的平均时间为29.9分钟（RF组）和35.0分钟（MF组）（95%置信区间0.77 - 0.94，P = 0.012）。到达盲肠的平均时间为15.4分钟（RF组），而MF组为20.2分钟（P = 0.001）。RF组术后需要观察的患者比例较低，为0.97%，而MF组为9.8%（P = 0.022）。接受瑞马唑仑治疗的患者报告的平均疼痛评分较低（平均2.25分（RF组）对3.25分（MF组），P = 0.012），总体满意度评分较高（4.65分对4.33分，P = 0.012）。
本研究表明，在结肠镜检查筛查的清醒镇静中，瑞马唑仑联合芬太尼明显优于咪达唑仑联合芬太尼，具有更短的检查时间、更少的术后观察需求、更低的患者疼痛评分和更高的患者满意度。
