Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, People's Republic of China.
Affiliated Cancer Hospital, School of Medicine, UESTC, Chengdu, People's Republic of China and Affiliated Cancer Hospital School of Medicine, University of Electronic Science and Technology of China, Sichuan Cancer Hospital and Institute.
Pain Physician. 2023 Nov;26(7):E761-E773.
Remimazolam is a novel ultrashort-effect benzodiazepine. In 2020, the US Food and Drug Administration approved it for procedural sedation. Remimazolam is beneficial for consistent sedation and quick recovery in painless gastrointestinal endoscopy. Propofol is one of the most commonly used intravenous anesthetics in clinical practice. Recently, only a few studies have compared propofol with remimazolam for general anesthesia induction.
The purpose of our systematic review and meta-analysis was to compare the hemodynamic effects of remimazolam and propofol during the induction of general anesthesia.
Systematic review and meta-analysis of randomized, controlled trials.
The authors retrieved the PubMed, Embase, Cochrane Library, and Web of Science databases for studies published through September 30, 2022, which reported relevant prospective randomized controlled trials (RCTs) comparing remimazolam with propofol for general anesthesia. The primary outcome was hemodynamic changes, including the absolute value of fluctuation of mean arterial pressure (delta MAP) and heart rate delta HR). The secondary outcomes were the following 2 indicators: the occurrence of total adverse events and the quality of recovery from general anesthesia at 24 hours postsurgery. RevMan 5.4.1 (The Nordic Cochrane Centre for The Cochrane Collaboration) and trial sequential analysis were used to execute the statistical analyses. The different domains of bias were judged by the Cochrane risk of the bias assessment tool.
The authors identified 189 papers in PubMed, Embase, Cochrane Library, and Web of Science. Eight articles with 964 patients were selected. The included studies had moderate quality. For primary outcomes, the lower delta HR (mean difference [MD] = -4.99; 95% CI, -7.97 to -2.00; I² = 41.6%; P = 0.001] and delta MAP (MD = -5.91; 95% CI. -8.57 to -3.24; I² = 0%; P < 0.0001) represent more stable hemodynamic characteristics in the remimazolam group. Regarding secondary outcomes, a considerably lower incidence of total adverse events was noted in the remimazolam group than that for the propofol group (odds ratio [OR] = 0.40; 95% CI, 0.28 to 0.58; I² = 63%; P < 0.00001). In comparison to the propofol group, remimazolam achieved an advantage score of quality of recovery -15 in 24 hours postsurgery (MD = 5.31, 95% CI, 1.51 to 9.12; I² = 87%; P = 0.006).
Firstly, there are only a handful of published RCTs on the administration of remimazolam in general anesthesia. In addition, due to patient privacy, we could not extract individual patient data, therefore we could not combine and assess any variations in patient characteristics.
Evidence suggests that remimazolam has a lower hemodynamic effect during general anesthesia and fewer perioperative adverse effects after general anesthesia than propofol; however, which agent is superior regarding quality benefit in postoperative recovery based on the studies included here remains inconclusive. Additional RCTs with updated meta-analyses to enlarge the sample size and properly analyze the benefit-to-risk ratio to patients are needed to determine the evidence for such a relatively new medicine.
雷米唑仑是一种新型超短效苯二氮䓬类药物。2020 年,美国食品和药物管理局批准其用于程序镇静。雷米唑仑有利于无痛胃肠内镜检查中持续镇静和快速恢复。丙泊酚是临床实践中最常用的静脉麻醉剂之一。最近,只有少数研究比较了丙泊酚和雷米唑仑用于全身麻醉诱导。
本系统评价和荟萃分析的目的是比较雷米唑仑和丙泊酚在全身麻醉诱导期间的血液动力学效应。
系统评价和随机对照试验的荟萃分析。
作者检索了PubMed、Embase、Cochrane 图书馆和 Web of Science 数据库,以获取截至 2022 年 9 月 30 日发表的相关前瞻性随机对照试验(RCT),报告了雷米唑仑与丙泊酚用于全身麻醉的比较。主要结局是血液动力学变化,包括平均动脉压(delta MAP)和心率 delta HR)的绝对值变化。次要结局是总不良事件的发生和术后 24 小时全身麻醉恢复质量。RevMan 5.4.1(北欧 Cochrane 中心 Cochrane 协作组)和试验序贯分析用于执行统计分析。不同领域的偏倚由 Cochrane 偏倚评估工具判断。
作者在 PubMed、Embase、Cochrane 图书馆和 Web of Science 中确定了 189 篇论文。选择了 8 篇包含 964 名患者的文章。纳入的研究质量中等。对于主要结局,雷米唑仑组的 delta HR(平均差[MD]=-4.99;95%CI,-7.97 至-2.00;I²=41.6%;P=0.001)和 delta MAP(MD=-5.91;95%CI,-8.57 至-3.24;I²=0%;P<0.0001)值更稳定,表明血液动力学特征更稳定。关于次要结局,雷米唑仑组总不良事件发生率明显低于丙泊酚组(比值比[OR]=0.40;95%CI,0.28 至 0.58;I²=63%;P<0.00001)。与丙泊酚组相比,雷米唑仑组在术后 24 小时的恢复质量评分高出 15 分(MD=5.31;95%CI,1.51 至 9.12;I²=87%;P=0.006)。
首先,关于雷米唑仑在全身麻醉中的应用,仅有少数已发表的 RCT。此外,由于患者隐私,我们无法提取个体患者数据,因此无法对患者特征的任何变化进行组合和评估。
证据表明,与丙泊酚相比,雷米唑仑在全身麻醉期间具有较低的血液动力学效应,全身麻醉后围手术期不良事件较少;然而,基于这里纳入的研究,关于术后恢复质量获益方面哪种药物更具优势尚不确定。需要更多的 RCT 进行更新的荟萃分析,以扩大样本量并正确分析对患者的获益-风险比,以确定这种相对较新的药物的证据。