Adverse event analysis.

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 (RT group), the propofol group (P group), and the remimazolam tosylate plus propofol group(R+T group). The primary outcome was the incidence of hypotension. Secondary outcomes included the results of sedation and recovery. The safety results mainly include the incidence of Hypotension, adverse respiratory events, postoperative nausea and vomiting, hiccup, cough, body movement and bradycardia.
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, three groups of pairwise comparisons showed statistical differences, 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.
Trial registration
Clinical trial registration number:NCT05429086.

## 研究背景
低血压是丙泊酚（propofol）介导镇静时最常见的不良事件，且可能对患者造成不同程度的损害。而甲苯磺酸瑞马唑仑（remimazolam tosylate）的镇静效果弱于丙泊酚。

## 研究目的
本研究旨在探讨甲苯磺酸瑞马唑仑联合丙泊酚的应用优势。

## 研究方法
本研究共纳入304例患者，分为甲苯磺酸瑞马唑仑组（RT组）、丙泊酚组（P组）以及甲苯磺酸瑞马唑仑联合丙泊酚组（R+P组）。本研究的主要结局指标为低血压发生率；次要结局指标包括镇静效果与复苏情况；安全性指标主要包括低血压、呼吸不良事件、术后恶心呕吐、呃逆、咳嗽、体动反应及心动过缓的发生率。

## 研究结果
P组低血压发生率为56.7%，RT组为12.6%，R+P组为31.3%，三组间两两比较均存在统计学差异（P<0.001）。RT组体动反应发生率（26.1%）显著高于P组（10.3%）与R+P组（12.5%），P=0.004。内镜医师满意度方面，P组（3.87±0.44）与R+P组（3.95±0.22）均高于RT组（3.53±0.84）。不良事件发生率由高到低依次为P组、RT组、R+P组（93.8% vs. 61.3% vs. 42.7%）。

## 研究结论
联合用药组的不良事件发生率低于丙泊酚单药治疗组，同时其镇静效果优于甲苯磺酸瑞马唑仑单药治疗组，且内镜医师满意度更高。

## 临床试验注册
临床试验注册号：NCT05429086。