Ogura Kanako, Ichijima Ryoji, Ikehara Hisatomo, Sugita Tomomi, Yamaguchi Daisuke, Nagata Yasuhiko, Esaki Mitsuru, Minoda Yosuke, Ono Hiroyuki, Hotta Kinichi, Kiriyama Shinsuke, Sumiyoshi Tetsuya, Kanmura Yuichi
Department of Medicine Nihon University School of Medicine Division of Gastroenterology and Hepatology Tokyo Japan.
Department of Gastroenterology Nagata Surgery and Gastroenterological Clinic Tokyo Japan.
DEN Open. 2024 Jul 23;5(1):e412. doi: 10.1002/deo2.412. eCollection 2025 Apr.
To compare the efficacy and safety of sedation with midazolam and remimazolam for colorectal endoscopy.
This single-center, two-arm, post-hoc analysis of the REM-IICTJP01 study investigated the efficacy and safety of remimazolam for gastrointestinal endoscopic sedation. We enrolled 40 and 208 patients who underwent colonoscopy under remimazolam and midazolam sedation, respectively, during the same period. The primary outcome was the time from the end of the colonoscopy until discharge. The secondary outcomes included the time from the end of the colonoscopy until awakening, dosage, and adverse events. Propensity score matching was employed to eliminate the effect of confounding factors.
Thirty-seven patients in each group were matched. After propensity matching, the time to awakening after colonoscopy was 28.0 (13.0-37.0) min in the midazolam group and 0 (0-0) min in the remimazolam group; moreover, the time till discharge was 40.0 (35.0-46.5) min in the midazolam group and 0 (0-5.0) min in the remimazolam group, both of which were significantly shorter in the remimazolam group ( < 0.01). The number of additional doses was 0 (0-0) and 2 (1-3) in the midazolam and remimazolam groups, respectively. The total dose was 2.0 (2.0-3.5) and 6.0 (5.0-7.0) mg in the midazolam and remimazolam groups, respectively.
Remimazolam yielded significantly faster times to awakening and discharge safely compared to midazolam.
比较咪达唑仑和瑞米唑仑用于结直肠内镜检查镇静的有效性和安全性。
本研究为对REM-IICTJP01研究的单中心、双臂事后分析，旨在探究瑞米唑仑用于胃肠内镜检查镇静的有效性和安全性。我们纳入了同期分别接受瑞米唑仑和咪达唑仑镇静下行结肠镜检查的40例和208例患者。主要结局指标为结肠镜检查结束至出院的时间。次要结局指标包括结肠镜检查结束至苏醒的时间、用药剂量及不良事件。采用倾向得分匹配法以消除混杂因素的影响。
每组匹配37例患者。倾向得分匹配后，咪达唑仑组结肠镜检查后苏醒时间为28.0（13.0 - 37.0）分钟，瑞米唑仑组为0（0 - 0）分钟；此外，咪达唑仑组至出院时间为40.0（35.0 - 46.5）分钟，瑞米唑仑组为0（0 - 5.0）分钟，瑞米唑仑组的这两个时间均显著更短（<0.01）。咪达唑仑组和瑞米唑仑组追加剂量数分别为0（0 - 0）和2（1 - 3）。咪达唑仑组和瑞米唑仑组总剂量分别为2.0（2.0 - 3.5）毫克和6.0（5.0 - 7.0）毫克。
与咪达唑仑相比，瑞米唑仑能使患者苏醒和出院时间显著加快且安全性良好。
