Introduction: Hypotension is the most common adverse event under propofol-mediated sedation and is possible to cause varying degrees of damage to patients. Whereas remimazolam has a poorer sedative effect than propofol. Aim: The aim of this study was to explore the advantages of the combination of remimazolam tosylate and propofol. Methods: 304 patients were divided into the remimazolam tosylate group, the propofol group, and the remimazolam tosylate plus propofol group. The primary outcome was the incidence of hypotension. Secondary outcomes included the results of sedation and recovery. Results: The incidence of hypotension was 56.7% in the P group, 12.6% in the RT group, and 31.3% in the R+P group, with P< 0.001. The incidence of body movement was significantly higher in the RT group (26.1%) than in the P group (10.3%) and the R+P group (12.5%), P=0.004. The endoscopist satisfaction was higher in the P (3.87±0.44) and R+P (3.95±0.22)groups than in the RT(3.53±0.84) group. The incidence of adverse events, in descending order, was P group, RT group, and R+P group (93.8%vs.61.3%vs.42.7%). Conclusion: Co-administration had fewer adverse events than propofol monotherapy, also had a better sedative effect and higher endoscopist satisfaction than remimazolam monotherapy. Clinical trial registration number: NCT05429086

中文翻译：

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甲苯磺酸瑞马唑仑联合丙泊酚用于上消化道内镜检查的安全性和有效性：一项多中心、随机临床试验

简介：低血压是丙泊酚介导镇静下最常见的不良事件，可能对患者造成不同程度的损害。而瑞马唑仑的镇静作用比丙泊酚差。目的：本研究旨在探讨甲苯磺酸瑞马唑仑与异丙酚联合用药的优势。方法：304例患者分为甲苯磺酸瑞马唑仑组、丙泊酚组和甲苯磺酸瑞马唑仑联合丙泊酚组。主要结果是低血压的发生率。次要结果包括镇静和恢复的结果。结果：P组低血压发生率为56.7%，RT组为12.6%，R+P组为31.3%，P<0.001。RT 组的身体运动发生率 (26.1%) 明显高于 P 组 (10.3%) 和 R+P 组 (12. 5%), P=0.004。P组（3.87±0.44）和R+P组（3.95±0.22）内镜医师满意度高于RT组（3.53±0.84）。不良事件发生率从高到低依次为P组、RT组、R+P组（93.8% vs.61.3% vs.42.7%）。结论：与异丙酚单药治疗相比，联合用药的不良事件更少，镇静效果更好，内镜医师满意度也高于瑞马唑仑单药治疗。临床试验注册号：NCT05429086 也比瑞马唑仑单一疗法具有更好的镇静效果和更高的内镜医师满意度。临床试验注册号：NCT05429086 也比瑞马唑仑单一疗法具有更好的镇静效果和更高的内镜医师满意度。临床试验注册号：NCT05429086