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瑞马唑仑给药后术后谵妄的发生率及预测因素:29项随机试验的系统评价和荟萃分析

Incidence and predictors of postoperative delirium following remimazolam administration: a systematic review and meta-analysis of 29 randomized trials.

作者信息

Li Chao, Wei Lai, Gong Hong, Yuan Xingxing

机构信息

Department of Anesthesiology, Hunan Provincial People'S Hospital (the First Affiliated Hospital of Hunan Normal University), Changsha, China.

出版信息

BMC Anesthesiol. 2025 Apr 23;25(1):201. doi: 10.1186/s12871-025-03018-w.

DOI:10.1186/s12871-025-03018-w
PMID:40269722
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12016161/
Abstract

BACKGROUND

Postoperative delirium is a significant and common complication in surgical patients, particularly in vulnerable populations such as the elderly. Remimazolam, a novel benzodiazepine, has been introduced as an anesthetic agent with a favorable pharmacokinetic profile. However, its potential association with postoperative delirium remains unclear. This study aims to systematically synthesize available evidence on the incidence of delirium following remimazolam administration in surgical patients. We sought to identify significant moderators of delirium incidence and to explore predictors of delirium through meta-regression analysis.

METHODS

A comprehensive literature search was conducted across multiple databases, including PubMed, Scopus, Web of Science, Cochrane Library, and Google Scholar, up to May 20, 2024. The search was updated on Feb 2nd, 2025. Randomized trials were selected based on predefined criteria, and data on patient characteristics, surgical details, and delirium incidence were extracted. A meta-analysis was performed to calculate the pooled incidence rate of delirium, and subgroup and meta-regression analyses were conducted to identify incidence rate moderators.

RESULTS

A total of 29 RCTs, including 2,435 patients, were analyzed. The pooled incidence of postoperative delirium following remimazolam administration was 5% (95%CI: 3-7%). ASA III-IV patients had a delirium rate of 19% (95%CI: 15-23%) compared to 1% (95%CI: 0-1%) for ASA I-II. Age was a key factor, with children showing the highest rate (11%, 95%CI: 3-19%), followed by elderly patients (8%, 95%CI: 4-13%), while adults had the lowest (1%, 95%CI: 0-2%). Delirium incidence was highest in oncologic (16%, 95%CI: 0-34%) and orthopedic surgeries (12%, 95%CI: 9-14%), and lowest in gastrointestinal and endoscopic procedures (0%, 95%CI: 0-1%). High-dose remimazolam was linked to the lowest delirium incidence, while moderate doses had higher rates. Meta-regression identified surgery type as the primary predictor, with orthopedic surgery having the highest risk compared to laparoscopic and abdominal procedures (coefficient = 0.081, p = 0.03).

CONCLUSIONS

Postoperative delirium occurs in 5% of surgical patients following remimazolam administration. Key moderators include ASA classification, age, surgery type, and anesthetic dosing. Remimazolam may be safely used in surgical patients, particularly when higher doses are administered, but caution is warranted in high-risk populations such as elderly patients and those undergoing complex surgical procedures.

摘要

背景

术后谵妄是外科手术患者中一种重要且常见的并发症,在老年人等脆弱人群中尤为常见。瑞马唑仑是一种新型苯二氮䓬类药物,作为一种具有良好药代动力学特征的麻醉剂被引入。然而,其与术后谵妄的潜在关联仍不明确。本研究旨在系统地综合有关外科手术患者使用瑞马唑仑后谵妄发生率的现有证据。我们试图确定谵妄发生率的显著调节因素,并通过Meta回归分析探索谵妄的预测因素。

方法

截至2024年5月20日,在多个数据库中进行了全面的文献检索,包括PubMed、Scopus、Web of Science、Cochrane图书馆和谷歌学术。检索于2025年2月2日更新。根据预定义标准选择随机试验,并提取患者特征、手术细节和谵妄发生率的数据。进行Meta分析以计算谵妄的合并发生率,并进行亚组分析和Meta回归分析以确定发生率的调节因素。

结果

共分析了29项随机对照试验,包括2435例患者。使用瑞马唑仑后术后谵妄的合并发生率为5%(95%CI:3-7%)。ASA III-IV级患者的谵妄发生率为(95%CI:15-23%),而ASA I-II级患者为1%(95%CI:0-1%)。年龄是一个关键因素,儿童的发生率最高(11%,95%CI:3-19%),其次是老年患者(8%,95%CI:4-13%),而成年人最低(1%,95%CI:0-2%)。谵妄发生率在肿瘤手术(16%,95%CI:0-34%)和骨科手术(12%,95%CI:9-14%)中最高且在胃肠和内镜手术中最低(0%,95%CI:0-1%)。高剂量瑞马唑仑与最低的谵妄发生率相关,而中等剂量的发生率较高。Meta回归确定手术类型是主要预测因素,与腹腔镜和腹部手术相比,骨科手术的风险最高(系数=0.081,p=0.03)。

结论

外科手术患者使用瑞马唑仑后,5%会发生术后谵妄。关键调节因素包括ASA分级、年龄、手术类型和麻醉剂量。瑞马唑仑可安全用于外科手术患者,特别是在使用较高剂量时,但对于老年患者和接受复杂手术的患者等高风险人群,仍需谨慎使用。

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