关键词: Adverse drug events Bradycardia General anesthesia General surgery Hypotension Hypoxemia Pain at injection site Propofol Remimazolam Respiratory depression

Mesh : Humans Anesthesia, General / adverse effects Anesthetics, Intravenous / adverse effects Benzodiazepines / adverse effects therapeutic use Hypotension / chemically induced Postoperative Nausea and Vomiting / epidemiology Propofol / adverse effects therapeutic use

来  源:   DOI:10.1007/s12325-024-02820-1

Abstract:
BACKGROUND: Developments in anesthetic pharmacology have been aiming at minimizing physiological disturbance in addition to maintaining and improving titrateability, recovery profile, and patient experience. Remimazolam, a GABAAlpha receptor agonist, is a new intravenous anesthetic agent which has recently been approved for use. This analysis aimed to systematically compare the adverse drug events reported with the newly approved remimazolam in comparison to propofol for general anesthesia (GA) in patients undergoing surgery.
METHODS: Electronic databases were searched from 15 May to 20 December 2023 for relevant publications which compared the outcomes reported with the newly approved remimazolam versus propofol in patients undergoing surgery. Relevant reported adverse drug events were the endpoints of this study. The statistical analysis was carried out using the latest version of the RevMan software. Data analysis was represented by risk ratio (RR) with 95% confidence intervals (CI).
RESULTS: Sixteen studies with a total number of 1897 participants were included in this analysis; 1104 participants received remimazolam and 793 participants received propofol. The risks for hypotension (RR 0.50, 95% CI 0.43-0.58; P = 0.00001), hypoxemia (RR 0.43, 95% CI 0.19-0.99; P = 0.05), bradycardia (RR 0.53, 95% CI 0.36-0.78; P = 0.001), pain at injection site (RR 0.07, 95% CI 0.01-0.56; P = 0.01), and total adverse events (RR 0.33, 95% CI 0.24-0.47; P = 0.00001) were significantly lower with remimazolam. However, no significant differences were observed in terms of postoperative nausea and vomiting (RR 0.98, 95% CI 0.66-1.46; P = 0.93), dizziness (RR 0.42, 95% CI 0.11-1.57; P = 0.20), psychiatric symptoms (RR 1.09, 95% CI 0.45-2.67; P = 0.85), and respiratory depression (RR 0.81, 95% CI 0.24-2.76; P = 0.74).
CONCLUSIONS: Our current analysis showed that the newly approved remimazolam was apparently associated with significantly fewer adverse drug events in comparison to propofol for GA in patients undergoing surgery. Therefore, this new drug should be further studied and more research with larger population sizes should be carried out to confirm this hypothesis.
摘要:
背景:麻醉药理学的发展除了维持和改善滴定能力外,还旨在最大程度地减少生理干扰,恢复配置文件,和病人的经验。雷米唑仑,一种GABAα受体激动剂,是一种新的静脉麻醉剂,最近已被批准使用。该分析旨在系统地比较新批准的雷米马唑仑与丙泊酚用于手术患者全身麻醉(GA)的不良反应。
方法:从2023年5月15日至12月20日检索了电子数据库,查找相关出版物,比较了新批准的瑞马唑仑与丙泊酚在手术患者中的结果。相关报告的药物不良事件是本研究的终点。使用最新版本的RevMan软件进行统计分析。数据分析以风险比(RR)和95%置信区间(CI)表示。
结果:本分析包括16项研究,总人数为1897名参与者;1104名参与者接受雷米马唑仑,793名参与者接受异丙酚。低血压的风险(RR0.50,95%CI0.43-0.58;P=0.00001),低氧血症(RR0.43,95%CI0.19-0.99;P=0.05),心动过缓(RR0.53,95%CI0.36-0.78;P=0.001),注射部位疼痛(RR0.07,95%CI0.01-0.56;P=0.01),和总不良事件(RR0.33,95%CI0.24-0.47;P=0.00001)显著低于雷米唑仑。然而,术后恶心和呕吐无显著差异(RR0.98,95%CI0.66-1.46;P=0.93),头晕(RR0.42,95%CI0.11-1.57;P=0.20),精神症状(RR1.09,95%CI0.45-2.67;P=0.85),和呼吸抑制(RR0.81,95%CI0.24-2.76;P=0.74)。
结论:我们目前的分析表明,在接受手术的患者中,与丙泊酚相比,新批准的瑞咪唑安定与明显更少的药物不良事件相关。因此,这种新药应该进一步研究,应该进行更多的研究以证实这一假设。
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