雷马唑仑与异丙酚在电视胸腔镜手术麻醉诱导中的应用:一项多中心随机对照试验的研究方案

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Trials Pub Date : 2025-05-26 DOI:10.1186/s13063-025-08833-7
Lu Zhang, Juan Yang, Lu Zhou, Hong Yu, Bin Liu, Leng Zhou
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引用次数: 0

摘要

背景:术中低血压可导致较高的术后心肌损伤、急性肾损伤和脑卒中发生率。值得注意的是,超过一半的术中低血压病例是在全麻诱导后立即发生的。虽然术中低血压有多种原因,但诱导后低血压主要是由于麻醉药物的作用。异丙酚是应用最广泛的麻醉诱导剂。然而,异丙酚可引起血流动力学不稳定,可能导致不良的术后结果。雷马唑仑,一种新型的超短效静脉镇静催眠药,可能促进稳定的血流动力学。研究报道,与异丙酚相比,雷马唑仑与低血压的关系更小。因此,本研究旨在比较雷马唑仑和异丙酚在电视胸腔镜手术患者麻醉诱导过程中的血流动力学影响。方法:这是一项前瞻性、多中心随机对照试验。172名年龄在45 - 65岁之间接受电视胸腔镜手术的患者将被随机分配在麻醉诱导期间接受雷马唑仑或异丙酚。主要观察指标是麻醉诱导后20分钟内低血压的发生率。低血压的定义是收缩压(SBP)低于90 mmHg,或收缩压较基线降低30%以上,或服用血管活性药物。次要结局包括镇静成功率、镇静成功时间、诱导期咳嗽、术后7天内谵妄和术后住院死亡率。讨论:迄今为止,雷马唑仑很少用于电视胸腔镜手术的麻醉诱导。本研究将为雷马唑仑在这种手术环境下的血流动力学稳定性和麻醉效果提供重要信息。试验注册:中国临床试验注册中心ChiCTR2400085556。于2024年6月12日注册,http://www.chictr.org.cn/。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The use of remimazolam versus propofol for anesthesia induction in video-assisted thoracoscopic surgery: study protocol for a multicenter randomized controlled trial.

Background: Intraoperative hypotension may result in a higher incidence of postoperative myocardial injury, acute kidney injury, and stroke. Notably, more than half of intraoperative hypotension cases occur immediately after induction of general anesthesia. Although intraoperative hypotension has multiple causes, post-induction hypotension is primarily due to the effects of anesthetic drugs. Propofol is the most widely used agent for anesthesia induction. However, propofol can induce hemodynamic instability, potentially leading to adverse postoperative outcomes. Remimazolam, a novel ultra-short-acting intravenous sedative-hypnotic, may promote stable hemodynamics. Studies have reported that remimazolam is associated with less hypotension compared to propofol. Therefore, this study aims to compare the hemodynamic effects of remimazolam and propofol during anesthesia induction in patients undergoing video-assisted thoracoscopic surgery.

Methods: This is a prospective, multicenter randomized controlled trial. A total of 172 patients aged 45 to 65 years undergoing video-assisted thoracoscopic surgery will be randomly allocated to receive remimazolam or propofol during anesthetic induction. The primary outcome is the incidence of hypotension occurring within 20 min after anesthesia induction. Hypotension is defined as systolic blood pressure (SBP) of less than 90 mmHg, or a reduction of more than 30% in SBP from baseline, or the administration of vasoactive medication. Secondary outcomes include the rate of successful sedation, time to successful sedation, coughing during the induction period, postoperative delirium within 7 days after surgery, and postoperative in-hospital mortality.

Discussion: To date, remimazolam has rarely been used for anesthesia induction in video-assisted thoracoscopic surgery. This study will provide important information on hemodynamic stability and anesthesia efficacy of remimazolam in this surgical setting.

Trial registration: Chinese Clinical Trial Registry ChiCTR2400085556. Registered on 12 th June 2024, http://www.chictr.org.cn/ .

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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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