右美托咪定辅助镇痛对骨科手术后苏醒期谵妄的影响：一项随机对照试验。
Impact of dexmedetomidine supplemented analgesia on delirium in patients recovering from orthopedic surgery: A randomized controlled trial.
机构信息
Departments of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, 100034, China.
Department of Anesthesiology, Beijing Jishuitan Hospital, Beijing, China.
出版信息
BMC Anesthesiol. 2021 Sep 13;21(1):223. doi: 10.1186/s12871-021-01441-3.
BACKGROUND
Dexmedetomidine promotes normal sleep architecture; the drug also improves analgesia. We therefore tested the hypothesis that supplementing intravenous analgesia with dexmedetomidine reduces delirium in older patients recovering from orthopedic surgery.
METHODS
In this double-blinded randomized controlled trial, we enrolled 712 older (aged 65-90 years) patients scheduled for major orthopedic surgery. Postoperative analgesia was provided by patient-controlled intravenous sufentanil, supplemented by randomly assigned dexmedetomidine (1.25 μg/mL) or placebo, for up to three days. The primary outcome was the incidence of delirium assessed twice daily with the Confusion Assessment Method. Among secondary outcomes, pain severity was assessed twice daily and sleep quality once daily, each with an 11-point scale where 0 = no pain/the best possible sleep and 10 = the worst pain/the worst possible sleep.
RESULTS
The incidence of postoperative delirium was 7.3% (26 of 354) with placebo and 4.8% (17 of 356) with dexmedetomidine; relative risk 0.65, 95% CI 0.36 to 1.18; P = 0.151. Dexmedetomidine reduced pain both at rest (median difference -1 to 0 points, P ≤ 0.001) and with movement (-1 points, P < 0.001) throughout the first 5 postoperative days; it also improved subjective sleep quality during the first 3 postoperative days: day one median difference -1 point (95% CI -1 to 0), P = 0.007; day two 0 point (-1 to 0), P = 0.010; and day three 0 point (-1 to 0), P = 0.003. The incidence of adverse events was similar in each group.
CONCLUSIONS
Supplementing sufentanil intravenous analgesia with low-dose dexmedetomidine did not significantly reduce delirium, but improved analgesia and sleep quality without provoking adverse events.
TRIAL REGISTRATION
www.chictr.org.cn : ChiCTR1800017182 (Date of registration: July 17, 2018); ClinicalTrials.gov: NCT03629262 (Date of registration: August 14, 2018).
背景
右美托咪定促进正常的睡眠结构；该药物还可改善镇痛效果。因此，我们假设在静脉内给予阿片类药物镇痛的基础上加用右美托咪定可减少骨科手术后老年患者的谵妄。
方法
在这项双盲随机对照试验中，我们纳入了 712 名年龄在 65-90 岁的拟行大骨科手术的老年患者。术后镇痛采用患者自控静脉注射舒芬太尼，辅以随机分配的右美托咪定（1.25μg/mL）或安慰剂，最多持续 3 天。主要结局是采用意识模糊评估法（CAM）每天两次评估谵妄发生率。次要结局包括疼痛严重程度，每天两次评估，睡眠质量，每天一次评估，每个结局均采用 11 分制，其中 0=无痛/最佳睡眠，10=最痛/最差睡眠。
结果
安慰剂组和右美托咪定组术后谵妄发生率分别为 7.3%（26/354）和 4.8%（17/356）；相对风险 0.65，95%CI 0.36-1.18；P=0.151。右美托咪定在术后前 5 天内，无论静息时（中位数差值-1 到 0 分，P≤0.001）还是运动时（-1 分，P<0.001）均能减轻疼痛；同时在术后前 3 天内也改善了主观睡眠质量：第 1 天中位数差值-1 分（95%CI -1 到 0），P=0.007；第 2 天 0 分（-1 到 0），P=0.010；第 3 天 0 分（-1 到 0），P=0.003。两组的不良事件发生率相似。
结论
在舒芬太尼静脉内镇痛的基础上加用小剂量右美托咪定并未显著降低谵妄发生率，但改善了镇痛效果和睡眠质量，且无不良事件发生。
试验注册
www.chictr.org.cn：ChiCTR1800017182（注册日期：2018 年 7 月 17 日）；ClinicalTrials.gov：NCT03629262（注册日期：2018 年 8 月 14 日）。
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