Comparison of Remimazolam and Propofol in Recovery of Elderly Outpatients Undergoing Gastrointestinal Endoscopy: A Randomized, Non-Inferiority Trial.

IF 4.7 2区医学 Q1 CHEMISTRY, MEDICINAL

Drug Design, Development and Therapy Pub Date : 2024-09-28 eCollection Date: 2024-01-01 DOI:10.2147/DDDT.S474275

Lin Lu, Bing Chen, Xueli Zhao, Jie Zhai, Pan Zhang, Zhen Hua

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引用次数: 0

Abstract

Purpose: We designed this trial to compare the recovery time of remimazolam and propofol in elderly patients undergoing painless gastrointestinal endoscopy.

Patients and methods: In this randomized, non-Inferiority trial, 360 patients aged 65 years or older, scheduled for elective outpatient gastrointestinal endoscopy, were randomly assigned to the remimazolam combined with fentanyl (RF) group or the propofol combined with fentanyl (PF) group. The primary outcome was the post-anesthesia care unit (PACU) stay time, defined as the time from the end of the examination to scoring 9 points using the Modified Post-Anesthetic Discharge Scoring System (MPADSS) criteria. Secondary outcomes included sedation-related adverse events, recall, injection pain, as well as postoperative Quality of Recovery-15 (QoR-15) scores and Pittsburgh Sleep Quality Index (PSQI) scores at 1 day, 1 week, and 1 month postoperatively.

Results: A total of 351 patients completed the study, with 174 receiving remimazolam and 177 receiving propofol. The PACU stay time in RF group was non-inferior to that in PF group [14 (11, 18) vs 13 (10, 17), mean difference 1 (95% confidence interval 0, 2), P=0.084 for noninferiority]. However, remimazolam was associated with lower rate of hypoxemia [4.7% (8/180) vs 12.4% (22/180), P=0.011], reduced use of vasoactive drugs [1 (0, 1) vs 1 (1, 2), P<0.001], less injection pain [2 (1.2%) vs 35 (21.3%), P<0.001], and lower recall [20 (11.8%) vs 36 (20.3%), P=0.034]. There were no differences in the QoR-15 scores and PSQI scores at postoperative 1 day, 1 week, and 1 month between groups.

Conclusion: This non-inferiority study revealed that in elderly outpatients undergoing gastrointestinal endoscopy, remimazolam achieved recovery times comparable to propofol, with fewer associated complications.

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比较瑞马唑仑和丙泊酚对接受消化道内窥镜检查的老年门诊病人的恢复效果：随机、非劣效试验。

目的：我们设计了这项试验，以比较瑞马唑仑和异丙酚对接受无痛胃肠道内窥镜检查的老年患者的恢复时间：在这项随机、非劣效试验中，360 名 65 岁或以上的患者被随机分配到瑞马唑仑联合芬太尼（RF）组或异丙酚联合芬太尼（PF）组，这些患者都计划接受择期门诊胃肠道内窥镜检查。主要结果是麻醉后护理病房（PACU）停留时间，即从检查结束到使用改良麻醉后出院评分系统（MPADSS）标准评分达到 9 分的时间。次要结果包括镇静相关不良事件、回忆、注射疼痛以及术后1天、1周和1个月的术后恢复质量-15（QoR-15）评分和匹兹堡睡眠质量指数（PSQI）评分：共有351名患者完成了研究，其中174人接受了瑞马唑仑治疗，177人接受了异丙酚治疗。RF组的PACU停留时间不劣于PF组[14 (11, 18) vs 13 (10, 17)，平均差异1（95%置信区间0, 2），P=0.084为不劣性]。然而，雷马唑仑与较低的低氧血症发生率[4.7% (8/180) vs 12.4% (22/180)，P=0.011]、减少血管活性药物的使用[1 (0, 1) vs 1 (1, 2)，PPP=0.034]相关。术后1天、1周和1个月的QoR-15评分和PSQI评分在组间无差异：这项非劣效性研究表明，对于接受消化道内窥镜检查的老年门诊患者，瑞马唑仑的恢复时间与异丙酚相当，相关并发症较少。

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.