Alfentanil Enhanced the Sedation of Remimazolam During Anaesthesia Induction in Patients Undergoing Urological Day Surgery: A Randomised Controlled Trial.

IF 4.7 2区医学 Q1 CHEMISTRY, MEDICINAL

Drug Design, Development and Therapy Pub Date : 2025-07-03 eCollection Date: 2025-01-01 DOI:10.2147/DDDT.S508941

Yuliu Lin, Qiuling Chen, Yeqing Liao, Bing Xu, Cuiwen Zhang, Jiaxin Luo, Susu Liu, Xiaoshan Wu, Xuehai Guan

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引用次数: 0

Abstract

Background: Remimazolam is a novel benzodiazepine sedative agent. Combining opioids with sedatives exerts a synergistic effect. The aim is to investigate whether alfentanil enhances sedative effects of remimazolam during anaesthesia induction in patients undergoing urological day surgery.

Methods: This was a single-centre, single-blinded, randomised clinical trial. The study was conducted between 1 September 2022 and 31 December 2023. We included 114 patients undergoing urological day surgery under general anaesthesia. Patients were randomly assigned to the RMZ-AF or AF-RMZ group (n=57). During induction, the RMZ-AF group received remimazolam then alfentanil, and the AF-RMZ group received alfentanil then remimazolam. Primary outcome was the time from remimazolam administration to loss of consciousness (LOC) during induction. Secondary outcomes included anaesthetic and surgical characteristics, vital signs, and adverse events.

Results: The time from remimazolam administration to LOC was shorter in the AF-RMZ group compared with the RMZ-AF group (87.3 [25.7] s vs 132.3 [32.3] s, P<0.0001). Similarly, the time from remimazolam administration to a bispectral index (BIS) ≤ 60 was shorter in the AF-RMZ group compared with the RMZ-AF group (168.2 [58.1] s vs 207.8 [61.6] s, P=0.0006). Although no significant difference in the total amount of remimazolam administration between groups was observed, the RMZ-AF group required a higher dose of remimazolam to achieve LOC (P<0.0001) and to reach a BIS of ≤ 60 (P=0.0058). No significant differences were observed between groups in the total administration of alfentanil, ephedrine, rocuronium, or crystalloid infusion volumes. The most common adverse events were hypotension, hypertension, and tachycardia, with no significant difference between groups.

Conclusion: Alfentanil enhanced remimazolam's sedative effects during anaesthesia induction in patients undergoing urological day surgery. The combination of remimazolam and alfentanil for general anaesthesia would improve efficacy, reducing the adverse effects and dosage of drug. But the potential mechanisms need further study.

Clinical trial registration: The trial was registered before patient enrolment at http://www.chictr.org.cn (ChiCTR2200064130, principal investigator: Xuehai Guan; date of registration: 27 September 2022, https://www.chictr.org.cn/showproj.html?proj=179023).

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阿芬太尼在泌尿外科日间手术患者麻醉诱导时增强雷马唑仑的镇静作用：一项随机对照试验。

背景：雷马唑仑是一种新型苯二氮卓类镇静剂。阿片类药物与镇静剂联用具有协同作用。目的是研究阿芬太尼是否能增强雷马唑仑在泌尿外科日间手术患者麻醉诱导中的镇静作用。方法：这是一项单中心、单盲、随机临床试验。该研究于2022年9月1日至2023年12月31日期间进行。我们纳入了114例在全身麻醉下接受泌尿外科日间手术的患者。患者被随机分为RMZ-AF组或AF-RMZ组（n=57）。诱导时，RMZ-AF组先给雷马唑仑后给阿芬太尼，AF-RMZ组先给阿芬太尼后给雷马唑仑。主要观察指标为诱导过程中从给予雷马唑仑到意识丧失（LOC）的时间。次要结局包括麻醉和手术特征、生命体征和不良事件。结果：AF-RMZ组给药至LOC时间较RMZ-AF组短（87.3 [25.7]s vs 132.3 [32.3] s， PP=0.0006）。虽然两组之间雷马唑仑给药总量没有显著差异，但RMZ-AF组需要更高剂量的雷马唑仑才能达到LOC （PP=0.0058）。在阿芬太尼、麻黄碱、罗库溴铵的总给药量或晶体输液量方面，组间无显著差异。最常见的不良事件是低血压、高血压和心动过速，组间无显著差异。结论：阿芬太尼可增强雷马唑仑在泌尿外科日间手术麻醉诱导中的镇静作用。雷马唑仑与阿芬太尼合用全身麻醉可提高麻醉效果，减少不良反应，减少药物用量。但潜在的机制需要进一步研究。临床试验注册：患者入组前注册，登录http://www.chictr.org.cn (ChiCTR2200064130)，主要研究员：关雪海；注册日期：2022年9月27日，https://www.chictr.org.cn/showproj.html?proj=179023)。

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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.