School of Anesthesiology, Guizhou Medical University, Guiyang, China.
Department of Pharmacy, Guizhou Provincial Staff Hospital, Guiyang, China.
Minerva Anestesiol. 2023 Jun;89(6):553-564. doi: 10.23736/S0375-9393.23.17034-9. Epub 2023 Feb 27.
Remimazolam is a novel sedative drug that has been successively approved for procedural sedation and general anesthesia, however, which has not been fully explored due to limited clinical studies and a small sample size. Current clinical studies have focused on the use of remimazolam and propofol for general anesthesia (GA) as indicators of safety outcomes in surgical patients, but different studies have reached different conclusions. The aim of this study was to investigate whether the safety-related outcome indicators in GA were superior to propofol in surgical patients.
We systematically searched PubMed, Cochrane Library, Embase, and Web of Science databases for all published randomized controlled trials comparing remimazolam with propofol for general anesthesia. Data from eligible studies were pooled with relative risk or mean differences to analyze the differences in hemodynamic stability and adverse effects of the two medications.
Eight randomized controlled trials involving 998 participants were included. Compared with propofol, remimazolam had better hemodynamic stability with a lower incidence of hypotension (RR=0.43, 95% CI: [0.34, 0.55], I=0%, P<0.00001), a higher preintubation, and immediate postintubation mean arterial pressure (MAP, MD=5.41, 95% CI: [5.26,11.24], Z=5.41, P<0.00001<0.05); (MD=1.60, 95% CI: [-0.20, 3.41], Z=1.74, P<0.08>0.05). Regarding other adverse events, the incidence of hypoxemia, nausea and vomiting, dizziness and injection site pain was lower in the remimazolam group compared to the propofol group.
In this Meta-analysis, compared with propofol, remimazolam for GA reduced the incidence of hypotension, hypoxemia, nausea and vomiting, dizziness and injection site pain, and had a more stable MAP before and after intubation, which supported that remimazolam is a safer sedative. However, a large sample is needed to validate this finding.
雷米唑仑是一种新型镇静药物，已相继获准用于程序镇静和全身麻醉，但由于临床研究有限且样本量小，尚未充分探索。目前的临床研究主要集中在雷米唑仑和丙泊酚用于全身麻醉（GA）作为手术患者安全结果的指标上，但不同的研究得出了不同的结论。本研究旨在探讨 GA 中与安全性相关的结局指标是否优于手术患者的丙泊酚。
我们系统地检索了 PubMed、Cochrane 图书馆、Embase 和 Web of Science 数据库，以获取所有比较雷米唑仑与丙泊酚用于全身麻醉的已发表随机对照试验。对合格研究的数据进行汇总，采用相对风险或均数差值分析两种药物的血液动力学稳定性和不良反应差异。
纳入 8 项随机对照试验，共 998 名参与者。与丙泊酚相比，雷米唑仑具有更好的血液动力学稳定性，低血压发生率较低（RR=0.43，95%CI：[0.34,0.55]，I=0%，P<0.00001），插管前和插管即刻平均动脉压（MAP）较高（MD=5.41，95%CI：[5.26,11.24]，Z=5.41，P<0.00001<0.05）；（MD=1.60，95%CI：[-0.20,0.34]，Z=1.74，P<0.08>0.05）。关于其他不良反应，雷米唑仑组的低氧血症、恶心呕吐、头晕和注射部位疼痛发生率低于丙泊酚组。
在这项 Meta 分析中，与丙泊酚相比，雷米唑仑用于 GA 可降低低血压、低氧血症、恶心呕吐、头晕和注射部位疼痛的发生率，并在插管前后使 MAP 更稳定，这支持雷米唑仑是一种更安全的镇静剂。然而，需要更大的样本量来验证这一发现。
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