Department of Anesthesiology, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
PLoS One. 2023 Aug 3;18(8):e0282930. doi: 10.1371/journal.pone.0282930. eCollection 2023.
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.
The aim of this study was to explore the advantages of the combination of remimazolam tosylate and propofol.
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.
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%).
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.
低血压是异丙酚介导镇静下最常见的不良反应，可能对患者造成不同程度的损害。而雷米唑仑的镇静效果不如异丙酚。
本研究旨在探讨托西酸雷米唑仑与异丙酚联合应用的优势。
将 304 例患者分为托西酸雷米唑仑组（RT 组）、异丙酚组（P 组）和托西酸雷米唑仑+异丙酚组（R+T 组）。主要结局是低血压的发生率。次要结局包括镇静和恢复结果。安全性结果主要包括低血压、呼吸不良事件、术后恶心呕吐、呃逆、咳嗽、躯体运动和心动过缓的发生率。
P 组低血压发生率为 56.7%，RT 组为 12.6%，R+P 组为 31.3%，三组两两比较差异有统计学意义，P<0.001。RT 组（26.1%）躯体运动发生率明显高于 P 组（10.3%）和 R+P 组（12.5%），P=0.004。P（3.87±0.44）和 R+P（3.95±0.22）组内镜医师满意度均高于 RT 组（3.53±0.84）。不良事件发生率依次为 P 组、RT 组和 R+P 组（93.8%vs.61.3%vs.42.7%）。
与异丙酚单药治疗相比，联合用药不良反应较少，与雷米唑仑单药治疗相比，镇静效果更好，内镜医师满意度更高。
临床试验注册号：NCT05429086。
