Department of Anaesthesiology, Centre for Anaesthesiogical Research, Zealand University Hospital, Køge, Denmark.
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Acta Anaesthesiol Scand. 2023 Apr;67(4):382-411. doi: 10.1111/aas.14208. Epub 2023 Feb 7.
To assess any benefit or harm, we conducted a systematic review of randomised clinical trials (RCTs) allocating adults to dexmedetomidine versus placebo/no intervention for the prevention of delirium in intensive care or post-operative care units.
We searched Medline, Embase, CENTRAL and other databases. The last search was 9 April 2022.
Literature screening, data extraction and risk of bias volume 2 assessments were performed independently and in duplicate. Primary outcomes were occurrences of serious adverse events (SAEs), delirium and all-cause mortality. We used meta-analysis, Trial Sequential Analysis, and GRADE (Grading Recommendations Assessment, Development and Evaluation).
Eighty-one RCTs (15,745 patients) provided data for our primary outcomes. Results from trials at low risk of bias showed that dexmedetomidine may reduce the occurrence of the most frequently reported SAEs (relative risk [RR] 0.69; 95% CI 0.43-1.09), cumulated SAEs (RR 0.70; 95% CI 0.52-0.95) and the occurrence of delirium (RR 0.62; 95% CI 0.43-0.89). The certainty of evidence was very low for delirium. Mortality was very low in trials at low risk of bias (0.4% in the dexmedetomidine groups and 1.0% in the control groups) and meta-analysis did not provide conclusive evidence that dexmedetomidine may result in lower or higher all-cause mortality (RR 0.47; 95% CI 0.18-1.21). There was a lack of information from trial results at low risk of bias for all primary outcomes.
Trial results at low risk of bias showed that dexmedetomidine might reduce occurrences of SAEs and delirium, while no conclusive evidence was found for effects on all-cause mortality. The certainty of evidence ranged from very low for occurrence of delirium to low for the remaining outcomes.
为了评估任何益处或危害，我们系统地回顾了随机临床试验（RCT），将成年人分配至右美托咪定与安慰剂/无干预用于预防重症监护或术后护理单元的谵妄。
我们检索了 Medline、Embase、CENTRAL 和其他数据库。最后一次检索日期为 2022 年 4 月 9 日。
文献筛选、数据提取和风险偏倚评估均由两名独立人员进行。主要结局指标为严重不良事件（SAEs）、谵妄和全因死亡率的发生情况。我们使用了荟萃分析、试验序贯分析和 GRADE（Grading Recommendations Assessment, Development and Evaluation）。
81 项 RCT（15745 名患者）为我们的主要结局指标提供了数据。来自低偏倚风险试验的结果表明，右美托咪定可能减少最常报告的 SAE（相对风险 [RR] 0.69；95%CI 0.43-1.09）、累积 SAE（RR 0.70；95%CI 0.52-0.95）和谵妄的发生（RR 0.62；95%CI 0.43-0.89）。对于谵妄，证据的确定性非常低。低偏倚风险试验中的死亡率非常低（右美托咪定组为 0.4%，对照组为 1.0%），荟萃分析并未提供确凿证据表明右美托咪定可能导致更低或更高的全因死亡率（RR 0.47；95%CI 0.18-1.21）。对于所有主要结局指标，低偏倚风险试验的结果均缺乏信息。
低偏倚风险的试验结果表明，右美托咪定可能减少 SAE 和谵妄的发生，但对于全因死亡率没有明确的证据。证据的确定性从谵妄的发生非常低到其他结局的低不等。
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