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[Lancet在线论文]:老年患者术中使用氯胺酮不能预防谵妄
2017年06月12日 时讯速递, 进展交流 暂无评论

Intraoperative ketamine for prevention of postoperative delirium or pain after major surgery in older adults: an international, multicentre, double-blind, randomised clinical trial

Michael S Avidan, Hannah R Maybrier, Arbi Ben Abdallah, et al.

Lancet 2017

DOI: http://dx.doi.org/10.1016/S0140-6736(17)31467-8

Summary

Background 背景

Delirium is a common and serious postoperative complication. Subanaesthetic ketamine is often administered intraoperatively for postoperative analgesia, and some evidence suggests that ketamine prevents delirium. The primary purpose of this trial was to assess the effectiveness of ketamine for prevention of postoperative delirium in older adults.

谵妄是常见且严重的术后并发症。术中常使用亚麻醉剂量的氯胺酮用于术后镇痛,一些证据提示氯胺酮能够预防谵妄。本研究的主要目的在于评价氯胺酮预防老年患者术后谵妄的效果。

Methods 方法学

The Prevention of Delirium and Complications Associated with Surgical Treatments [PODCAST] study is a multicentre, international randomised trial that enrolled adults older than 60 years undergoing major cardiac and non-cardiac surgery under general anaesthesia. Using a computer-generated randomisation sequence we randomly assigned patients to one of three groups in blocks of 15 to receive placebo (normal saline), low-dose ketamine (0·5 mg/kg), or high dose ketamine (1·0 mg/kg) after induction of anaesthesia, before surgical incision. Participants, clinicians, and investigators were blinded to group assignment. Delirium was assessed twice daily in the first 3 postoperative days using the Confusion Assessment Method. We did analyses by intention-to-treat and assessed adverse events. This trial is registered with clinicaltrials.gov, number NCT01690988.

PODCAST研究是一项多中心、国际、随机对照试验,入选接受全麻下心脏及非心脏大手术的年龄超过60岁的成年患者。我们采用计算机生成的随机序列,将患者随机分为3组(区组大小为15),即安慰剂(生理盐水),小剂量氯胺酮(0.5 mg/kg)或大剂量氯胺酮(1.0 mg/kg),于麻醉诱导后至手术切口前使用。患者、临床医生及研究者均对分组情况设盲。在苏后前3天,每日根据CAM-ICU进行2次谵妄评估。我们采用意向治疗分析,并评价不良反应。试验在clinical.gov网站注册,注册号NCT01690988。

Findings 结果

Between Feb 6, 2014, and June 26, 2016, 1360 patients were assessed, and 672 were randomly assigned, with 222 in the placebo group, 227 in the 0·5 mg/kg ketamine group, and 223 in the 1·0 mg/kg ketamine group. There was no difference in delirium incidence between patients in the combined ketamine groups and the placebo group (19·45% vs 19·82%, respectively; absolute difference 0·36%, 95% CI −6·07 to 7·38, p=0·92). There were more postoperative hallucinations (p=0·01) and nightmares (p=0·03) with increasing ketamine doses compared with placebo. Adverse events (cardiovascular, renal, infectious, gastrointestinal, and bleeding), whether viewed individually (p value for each >0·40) or collectively (36·9% in placebo, 39·6% in 0·5 mg/kg ketamine, and 40·8% in 1·0 mg/kg ketamine groups, p=0·69), did not differ significantly across groups.

2014年2月6日至2016年6月26日之间,共1360名患者接受评估,672名患者接受随机分组,其中安慰剂组222名,0.5 mg/kg氯胺酮组227名,1.0 mg/kg氯胺酮组223名。两个氯胺酮组合计,谵妄发生率与安慰剂组无差异(分别为19·45% vs 19·82%;绝对差异0·36%, 95% CI −6·07 to 7·38, p=0·92)。与安慰剂相比,随着氯胺酮剂量增加,术后幻觉(p=0·01) 及梦魇 (p=0·03) 的发生率增加。无论以个体计算(P > 0.40)抑或按照组别计算(安慰剂组36·9%,0·5 mg/kg 氯胺酮组39·6%,1·0 mg/kg氯胺酮组40·8%,p=0·69),不良事件(心血管,肾脏,感染,胃肠道及出血)在各组间均无显著差异。

Interpretation 结论

A single subanaesthetic dose of ketamine did not decrease delirium in older adults after major surgery, and might cause harm by inducing negative experiences.

单一的亚麻醉剂量氯胺酮不能减少大手术后老年患者的谵妄发生,而且可能因诱发负性经历导致损害。

Funding

National Institutes of Health and Cancer Center Support.

 

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