关注罂粟花，共同学习麻醉学最新文献！
比较瑞马唑仑和丙泊酚对门诊妇科手术术后麻醉满意度的影响：一项随机临床试验
贵州医科大学 麻醉与心脏电生理课题组
翻译：周倩 编辑：田明德 审校：曹莹
目的：本研究旨在比较瑞马唑仑和丙泊酚对妇科门诊手术患者术后麻醉满意度的影响。
患者和方法：这是一项单中心，开放性，非劣效性的随机临床试验。入选年龄≥18岁的门诊妇科手术镇静患者，主要终点是术后即刻麻醉满意度评分，通过爱荷华州麻醉满意度量表（ISAS）进行评估。
结果：168例患者被随机分配到瑞马唑仑组（n=84）或丙泊酚组（n=84）。手术后即刻的平均（标准差）ISAS评分：瑞马唑仑组1.7（0.6），丙泊酚组2.0（0.7）（差异为-0.2；97.5%置信区间[CI]：-0.5至-0.0；p=0.02），表明非劣效性。瑞马唑仑组麻醉后监护室（PACU）住院时间长于丙泊酚组（27.6[9.1]min vs 22.4[7.0]min；差异为5.2[95%CI:2.7〜7.6]min；p＜0.001）。瑞马唑仑组的高强度注射疼痛发生率低于丙泊酚组（3.6%比45.2%；差异为-41.7%[95%CI:-54.2%至-29.1%]；p＜0.001）。术后即刻瑞马唑仑组恶心评分高于丙泊酚组。术后第1天，瑞马唑仑组的疼痛，恶心，睡眠质量，焦虑和抑郁评分高于丙泊酚组。两组不良事件和其他次要终点的发生率相当。
结论：瑞马唑仑在妇科门诊手术患者术后麻醉满意度方面并不劣于丙泊酚。因此，在这种手术中，它应该被视为一种新的镇静替代品。
文献来源：Xu-Lin, Wang,Ling-Ling, Dai,Yan-Na, Li et al. Comparing Remimazolam and Propofol for Postoperative Anesthesia Satisfaction in Outpatient Gynecological Surgery: A Randomized Clinical Trial.[J] .Drug Des Devel Ther, 2024, 18: 4615-4627.
Comparing Remimazolam and Propofol for Postoperative Anesthesia Satisfaction in Outpatient Gynecological Surgery: A Randomized Clinical Trial.
Purpose: This study aimed to compare the efficacy of remimazolam and propofol regarding postoperative anesthesia satisfaction in patients undergoing outpatient gynecological surgery.
Patients and Methods:This was a single-center, open-label, non-inferiority, randomized clinical trial. Patients aged ≥ 18 years who underwent outpatient gynecological surgery with sedation were enrolled. Participants were randomly assigned to be sedated with remimazolam or propofol. The primary endpoint was the immediate postoperative anesthesia satisfaction score, evaluated through the Iowa Satisfaction with Anesthesia Scale (ISAS).
Results: 168 patients were randomly allocated to either the remimazolam group (n = 84) or the propofol group (n = 84). The mean (standard deviation) ISAS scores immediately after surgery were 1.7 (0.6) for the remimazolam group and 2.0 (0.7) for the propofol group (difference, –0.2; 97.5% confidence interval [CI]: –0.5 to –0.0; p = 0.02), indicating non-inferiority. The length of postanesthesia care unit (PACU) stay was longer in the remimazolam group than in the propofol group (27.6 [9.1] min vs 22.4 [7.0] min; difference, 5.2 [95% CI: 2.7 to 7.6] min; p < 0.001). High-intensity injection pain was less frequently observed in the remimazolam group than in the propofol group (3.6% vs 45.2%; difference, –41.7% [95% CI: –54.2% to –29.1%]; p < 0.001). The nausea score was higher in the remimazolam group immediately after surgery than in the propofol group. Pain, nausea, sleep quality, anxiety, and depression scores were higher in the remimazolam group than in the propofol group on postoperative day 1. The incidence of adverse events and other secondary endpoints was comparable between the two groups.
Conclusion: Remimazolam was non-inferior to propofol regarding postoperative anesthesia satisfaction in patients undergoing outpatient gynecological surgery. Therefore, it should be considered as a new sedation alternative in such procedures.
