PDF(Pubmed)
Abstract：
Study objective: The objective of the study was to evaluate the safety and efficacy of remimazolam besylate versus propofol injection in patients undergoing colonoscopy. Design: A multicenter, randomized, non-inferiority, single-blind, parallel-controlled clinical trial. Setting: Operating room. Patients: Patients aged 18-65 years (American Society of Anesthesiologists [ASA] classification I-III) undergoing a diagnostic or therapeutic colonoscopy. Interventions: Patients were administered intravenous injection of remimazolam besylate or propofol (active comparator) for sedation. Measurements: Modified Observer\'s Assessment of Alertness/Sedation [MOAA/S] scores of the included patients were assessed before dosing, 1, 1.5, 2, 2.5, and 3 min after the start of dosing, and then every 1 min until the MOAA/S score reached 5 on three consecutive occasions. Main Results: A total of 360 patients received remimazolam and 120 patients received propofol. The incidence of adverse events (67.8% vs. 84.2%, p = 0.001) was significantly lower in patients administered remimazolam compared to propofol. There was no significant difference in sedation success rates (full analysis set [FAS]: 98.9% vs. 99.2%; remimazolam vs. propofol). Remimazolam had a significantly longer onset of action, but the difference was not considered clinically significant (1.45 min vs. 1.24 min, remimazolam vs. propofol). Propofol achieved a deeper level of sedation (mean MOAA/S score 0.5 vs. 0.2; remimazolam vs. propofol). Mean time to discharge after the end of the last administration of study drug (20.3 vs. 21.8 min, p = 0.020) and incidence of injection pain was significantly lower in patients administered remimazolam (2.3% vs. 35.3%, p < 0.0001). Incidence of oxygen desaturation was significantly higher in patients administered propofol compared to patients administered remimazolam (6.7% vs. 1.1%, p = 0.001). Similarly, incidence of hypotension was more frequent in patients administered propofol compared to patients administered remimazolam (29.2% vs. 10.6%, p < 0.0001). Conclusion: Remimazolam besylate had a better safety and tolerability profile and similar sedative efficacy to propofol in patients undergoing a diagnostic or therapeutic colonoscopy in China, suggesting that remimazolam besylate has potential as a sedative agent for colonoscopy.
摘要：
研究目的：该研究的目的是评估在接受结肠镜检查的患者中，苯磺酸雷米马唑仑与丙泊酚注射的安全性和有效性。设计：多中心，随机化，非自卑，单盲,平行对照临床试验。设置：手术室。患者：18-65岁的患者（美国麻醉医师协会[ASA]I-III级）接受诊断性或治疗性结肠镜检查。干预措施：患者静脉注射苯磺酸瑞咪唑安定或异丙酚（活性比较剂）进行镇静。测量：在给药前评估纳入患者的改良观察者警报/镇静评估[MOAA/S]评分，给药开始后1、1.5、2、2.5和3分钟，然后每1分钟，直到连续三次MOAA/S得分达到5。主要结果：360例患者接受雷米咪唑安定治疗，120例患者接受丙泊酚治疗。不良事件发生率（67.8%vs.84.2%,p=0.001）与丙泊酚相比，服用瑞马唑仑的患者显着降低。镇静成功率无显著差异(完整分析集[FAS]：98.9%vs.99.2%;雷米唑仑与异丙酚）。雷米唑仑的起效时间明显更长，但差异被认为没有临床意义（1.45分钟与1.24分钟,雷米唑仑vs.异丙酚）。丙泊酚达到了较深的镇静水平（平均MOAA/S评分0.5vs.0.2；雷米唑仑与异丙酚）。最后一次给药研究药物结束后的平均出院时间（20.3vs.21.8分钟,p=0.020），注射疼痛的发生率在服用雷米马唑仑的患者中明显较低（2.3%vs.35.3%,p<0.0001)。丙泊酚患者的氧去饱和发生率明显高于雷米马唑仑患者（6.7%vs.1.1%,p=0.001)。同样，与服用雷米唑仑的患者相比，服用异丙酚的患者低血压的发生率更高(29.2%vs.10.6%,p<0.0001)。结论：在中国接受诊断性或治疗性结肠镜检查的患者中，苯磺酸雷米唑仑具有更好的安全性和耐受性，镇静效果与异丙酚相似。提示苯磺酸瑞米唑仑有可能作为结肠镜检查的镇静剂。
