术中输注右美托咪定对老年择期非心脏大手术患者术后谵妄与认知功能障碍的防治:一项随机临床实验
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Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium andCognitive Dysfunction in Elderly Patients Undergoing Major Elective Noncardiac Surgery: ARandomized Clinical Trial
背景与目的
重要性:术后谵妄发生在10%至60%的行大手术老年患者中,并与住院时间延长、医院费用增加和1年死亡率相关。新兴的文献表明,右美托咪定用于重症监护病房镇静与谵妄发生率降低相关。
目的:评价术中输注右美托咪定是否减少术后谵妄。
方 法
设计、设置和研究对象:这项研究是一项多中心、双盲、随机、安慰剂对照实验,手术过程中随机分为术中输注右美托咪定组和生理盐水安慰剂组并在康复室停留2个小时。日常评估患者术后谵妄(主要结果)和术后认知功能下降(次要地)的发生情况。研究对象均为老年(>68岁)择期非心脏大手术的患者。研究跨度为2008年2月到2014年5月。
干预:手术过程中静脉输注右美托咪啶(0.5 µg/kg/h),直到恢复室送入停留2小时。
主要结局和测量指标:实验的主要假设是术中使用右美托咪定可减少术后谵妄,其次该研究还对右美托咪定应用与术后认知变化之间的关系进行了检验。
结 果
总共有404名患者被随机分组;390名完成了住院谵妄评估(中位数[间距范围]年龄,74 [ 71.0-78.0 ]年;51.3% [ 200/390 ]女性)。右美托咪定和安慰剂组术后谵妄无差异((12.2% [23 of 189] vs 11.4% [23 of 201], P = 0.94)。调整年龄和教育水平后,治疗组3个月和6个月之间术后认知功能无差异。治疗组不良事件分布相同。
结 论
术中应用右美托咪定并不能预防术后谵妄。以前在许多外科ICU研究中得到证实的谵妄的减少并没有被观察到,这就突出了用药时防止谵妄的重要性。
原始文献摘要
Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium andCognitive Dysfunction in Elderly Patients Undergoing Major Elective Noncardiac Surgery: ARandomized Clinical Trial
Abstract
IMPORTANCE:
Postoperative delirium occurs in 10% to 60% of elderly patients having major surgery and is associated with longer hospital stays, increased hospital costs, and 1-year mortality. Emerging literature suggests that dexmedetomidine sedation in critical care units is associated with reduced incidence of delirium. However, intraoperative use of dexmedetomidine for prevention of delirium has not been well studied.
OBJECTIVE:
To evaluate whether an intraoperative infusion of dexmedetomidine reduces postoperative delirium.
DESIGN, SETTING, AND PARTICIPANTS:
This study was a multicenter, double-blind, randomized, placebo-controlled trial that randomly assigned patients to dexmedetomidine or saline placebo infused during surgery and for 2 hours in the recovery room. Patients were assessed daily for postoperative delirium (primary outcome) and secondarily for postoperative cognitive decline. Participants were elderly (>68 years) patients undergoing major elective noncardiac surgery. The study dates were February 2008 to May 2014.
INTERVENTIONS:
Dexmedetomidine infusion (0.5 µg/kg/h) during surgery and up to 2 hours in the recovery room.
MAIN OUTCOMES AND MEASURES:
The primary hypothesis tested was that intraoperative dexmedetomidine administration would reduce postoperative delirium. Secondarily, the study examined the correlation between dexmedetomidine use and postoperative cognitive change.
RESULTS:
In total, 404 patients were randomized; 390 completed in-hospital delirium assessments (median [interquartile range] age, 74.0 [71.0-78.0] years; 51.3% [200 of 390] female). There was no difference in postoperative delirium between the dexmedetomidine and placebo groups (12.2% [23 of 189] vs 11.4% [23 of 201], P = .94). After adjustment for age and educational level, there was no difference in the postoperative cognitive performance between treatment groups at 3 months and 6 months. Adverse events were comparably distributed in the treatment groups.
CONCLUSIONS AND RELEVANCE:
Intraoperative dexmedetomidine does not prevent postoperative delirium. The reduction in delirium previously demonstrated in numerous surgical intensive care unit studies was not observed, which underscores the importance of timing when administering the drug to prevent delirium.
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