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择期非心脏手术患者接受 Esketamine 麻醉后术后谵妄的日间变化:一项随机临床试验。

Diurnal variation of postoperative delirium in elderly patients undergoing esketamine anesthesia for elective noncardiac surgery: a randomized clinical trial.

机构信息

Department of Anesthesiology, Renmin Hospital of Wuhan University.

Department of Anesthesiology, East Hospital, Renmin Hospital of Wuhan University, Wuhan, People's Republic of China.

出版信息

Int J Surg. 2024 Sep 1;110(9):5496-5504. doi: 10.1097/JS9.0000000000001642.

DOI:10.1097/JS9.0000000000001642
PMID:39275772
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11392167/
Abstract

BACKGROUND

Postoperative delirium (POD) is a serious and common complication. The aim of present study is to investigate the diurnal variation of POD and the effects of esketamine in elderly patients.

METHODS

A randomized, double-blind, placebo-controlled clinical trial with factorial design was conducted. Patients (aged 65 to 85 years) with normal Mini-Mental State Examination (MMSE) score were stratified by age (≤70 vs. >70) and American Society of Anesthesiologists physical status classification (Ⅱ vs. Ⅲ), then randomly assigned to either morning (08:00-12:00) or afternoon (14:00-18:00) noncardiac operation under general anesthesia with or without esketamine administration (0.2 mg/kg). The primary outcome was the incidence of POD (3-Minute Diagnostic Interview for Confusion Assessment Method-defined Delirium, 3D-CAM) on postoperative days 1, 3, and 7. The secondary outcomes were the scores of MMSE and Hospital Anxiety and Depression Scale. The intention-to-treat analysis of the outcomes were performed by generalized estimating equation.

RESULTS

Six patients who did not receive an intervention because of canceled operation were excluded after randomization. The datasets containing 426 cases were analyzed following the intention-to-treat principle after handling missing data via multiple imputation method. The incidence of POD declined from about 55% on postoperative day 1 to 31 and 18% on postoperative days 3 and 7, respectively. Afternoon operation [B=-0.583, OR (95% CI) 0.558 (0.319-0.976); P=0.041], but not esketamine, significantly decreased the incidence of POD. Both esketamine and operation time failed to significantly affect MMSE, HAD, and NRS score. There was no interaction among operation time, esketamine, and follow up time.

CONCLUSION

Elderly patients undergoing elective noncardiac surgery in the afternoon displayed lower POD incidence than those operated in the morning. A single low-dose of esketamine before general anesthesia induction failed to significantly decrease the risk of POD but decrease the risk of intraoperative hypotension and emergence agitation.

摘要

背景

术后谵妄(POD)是一种严重且常见的并发症。本研究旨在探讨 POD 的昼夜变化规律及氯胺酮对老年患者的影响。

方法

采用随机、双盲、安慰剂对照的临床试验设计,将年龄(≤70 岁与>70 岁)和美国麻醉医师协会身体状况分级(Ⅱ级与Ⅲ级)分层的 MMSE 评分正常的老年患者(65-85 岁)随机分为全麻下非心脏手术的晨间(08:00-12:00)或午后(14:00-18:00)组,且分别给予或不给予氯胺酮(0.2mg/kg)。主要结局是术后第 1、3、7 天 3 分钟诊断性谵妄评估方法(3D-CAM)定义的 POD 发生率。次要结局是 MMSE 和医院焦虑抑郁量表(HADS)评分。采用广义估计方程对结局进行意向治疗分析。

结果

随机分组后,因手术取消未接受干预的 6 例患者被排除。采用多重插补法处理缺失数据后,根据意向治疗原则对包含 426 例病例的数据集进行分析。术后第 1 天 POD 的发生率约为 55%,第 3 天和第 7 天分别降至 31%和 18%。午后手术[B=-0.583,OR(95%CI)0.558(0.319-0.976);P=0.041]而非氯胺酮显著降低了 POD 的发生率。氯胺酮和手术时间均未显著影响 MMSE、HAD 和 NRS 评分。手术时间、氯胺酮和随访时间之间无交互作用。

结论

择期非心脏手术的老年患者在下午进行手术时 POD 的发生率低于上午。全麻诱导前单次低剂量氯胺酮虽未能显著降低 POD 的风险,但可降低术中低血压和苏醒期躁动的风险。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a3e/11392167/856325af35fb/js9-110-5496-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a3e/11392167/856325af35fb/js9-110-5496-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a3e/11392167/856325af35fb/js9-110-5496-g001.jpg

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