Comparing Remimazolam and Propofol for Postoperative Anesthesia Satisfaction in Outpatient Gynecological Surgery: A Randomized Clinical Trial.

IF 4.7 2区医学 Q1 CHEMISTRY, MEDICINAL Drug Design, Development and Therapy Pub Date : 2024-10-18 eCollection Date: 2024-01-01 DOI:10.2147/DDDT.S483029

Xu-Lin Wang, Ling-Ling Dai, Yan-Na Li, Jian-Wen Zhang, Ming-Cui Qu, Yao-Yao Zhou, Na Xing

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Abstract

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 post-anesthesia 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.

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比较雷马唑仑和丙泊酚在妇科门诊手术中的术后麻醉满意度：随机临床试验。

目的：本研究旨在比较瑞马唑仑和异丙酚对门诊妇科手术患者术后麻醉满意度的疗效：这是一项单中心、开放标签、非劣效、随机临床试验。参试者年龄≥18岁，在门诊妇科手术中使用镇静剂。参试者被随机分配使用瑞马唑仑或异丙酚镇静。主要终点是术后即时麻醉满意度评分，通过爱荷华麻醉满意度量表（ISAS）进行评估：168名患者被随机分配到瑞马唑仑组（84人）或异丙酚组（84人）。术后立即进行ISAS评分的平均值（标准差）为：瑞美唑仑组1.7（0.6）分，异丙酚组2.0（0.7）分（差异为-0.2；97.5%置信区间[CI]：-0.5至-0.0；P = 0.02），表明两者无劣效。麻醉后监护室（PACU）的停留时间在瑞马唑仑组长于异丙酚组（27.6 [9.1] 分钟 vs 22.4 [7.0] 分钟；差异为 5.2 [95% CI：2.7 至 7.6] 分钟；p < 0.001）。与异丙酚组相比，雷马唑仑组较少出现高强度注射疼痛（3.6% vs 45.2%；差异：-41.7% [95% CI：-54.2% to -29.1%]；p < 0.001）。术后立即服用瑞马唑仑组的恶心评分高于异丙酚组。术后第1天，瑞马唑仑组的疼痛、恶心、睡眠质量、焦虑和抑郁评分均高于异丙酚组。两组的不良事件和其他次要终点的发生率相当：结论：在门诊妇科手术患者的术后麻醉满意度方面，雷马唑仑并不比异丙酚差。因此，在此类手术中，应将其视为一种新的镇静替代方案。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.