Ceric Ameldina, Holgersson Johan, May Teresa L, Skrifvars Markus B, Hästbacka Johanna, Saxena Manoj, Aneman Anders, Delaney Anthony, Reade Michael C, Delcourt Candice, Jakobsen Janus Christian, Nielsen Niklas
Anesthesia & Intensive Care, Department of Clinical Sciences, Lund University, Skane University Hospital, Malmö, Sweden.
Lund University, Helsingborg Hospital, Department of Clinical Sciences Lund, Anesthesia & Intensive Care, Lund, Sweden.
EClinicalMedicine. 2024 Mar 28;71:102569. doi: 10.1016/j.eclinm.2024.102569. eCollection 2024 May.
BACKGROUND: Sedation is routinely administered to critically ill patients to alleviate anxiety, discomfort, and patient-ventilator asynchrony. However, it must be balanced against risks such as delirium and prolonged intensive care stays. This study aimed to investigate the effects of different levels of sedation in critically ill adults. METHODS: Systematic review with meta-analysis and trial sequential analysis (TSA) of randomised clinical trials including critically ill adults admitted to the intensive care unit. CENTRAL, MEDLINE, Embase, LILACS, and Web of Science were searched from their inception to 13 June 2023. Risks of bias were assessed using the Cochrane risk of bias tool. Primary outcome was all-cause mortality. Aggregate data were synthesised with meta-analyses and TSA, and the certainty of the evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. This study is registered with PROSPERO: CRD42023386960. FINDINGS: Fifteen trials randomising 4352 patients were included, of which 13 were assessed high risk of bias. Meta-analyses comparing lighter to deeper sedation showed no evidence of a difference in all-cause mortality (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.83-1.06; p = 0.28; 15 trials; moderate certainty evidence), serious adverse events (RR 0.99, CI 0.92-1.06; p = 0.80; 15 trials; moderate certainty evidence), or delirium (RR 1.01, 95% CI 0.94-1.09; p = 0.78; 11 trials; moderate certainty evidence). TSA showed that when assessing mortality, a relative risk reduction of 16% or more between the compared interventions could be rejected. INTERPRETATION: The level of sedation has not been shown to affect the risks of death, delirium, and other serious adverse events in critically ill adult patients. While TSA suggests that additional trials are unlikely to significantly change the conclusion of the meta-analyses, the certainty of evidence was moderate. This suggests a need for future high-quality studies with higher methodological rigor. FUNDING: None.
背景：通常会对重症患者进行镇静治疗，以缓解焦虑、不适和患者与呼吸机不同步的情况。然而，必须权衡其与诸如谵妄和延长重症监护住院时间等风险。本研究旨在调查不同镇静水平对成年重症患者的影响。 方法：对包括入住重症监护病房的成年重症患者在内的随机临床试验进行系统评价，并进行荟萃分析和试验序贯分析（TSA）。检索CENTRAL、MEDLINE、Embase、LILACS和Web of Science数据库，时间范围从建库至2023年6月13日。使用Cochrane偏倚风险工具评估偏倚风险。主要结局是全因死亡率。汇总数据通过荟萃分析和TSA进行综合分析，并使用推荐分级、评估、制定与评价（GRADE）方法评估证据的确定性。本研究已在PROSPERO注册：CRD42023386960。 结果：纳入了15项随机分配4352例患者的试验，其中13项被评估为高偏倚风险。比较轻度镇静与深度镇静的荟萃分析显示，在全因死亡率（风险比（RR）0.94，95%置信区间（CI）0.83 - 1.06；p = 0.28；15项试验；中等确定性证据）、严重不良事件（RR 0.99，CI 0.92 - 1.06；p = 0.80；15项试验；中等确定性证据）或谵妄（RR 1.01，95% CI 0.94 - 1.09；p = 0.78；11项试验；中等确定性证据）方面均无差异证据。TSA显示，在评估死亡率时，可以排除比较的干预措施之间相对风险降低16%或更多的情况。 解读：尚未发现镇静水平会影响成年重症患者的死亡、谵妄和其他严重不良事件风险。虽然TSA表明额外的试验不太可能显著改变荟萃分析的结论，但证据的确定性为中等。这表明未来需要开展方法学更严谨的高质量研究。 资金来源：无。
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