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临床试验/NCT02841423
NCT02841423Unknown不适用

Postoperative Cognitive Dysfunction After Intravenous Anesthesia or Closed-loop Coadministration of Propofol and Remifentanil Guided by Bispectral Index for Noncardiac Surgery : a Randomized Monocenter Study

Centre Hospitalier Universitaire de Besancon2 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2013年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
204
试验地点
2
主要终点
the incidence of early POCD in elderly patients (aged 55 yrs or older)

研究概览

简要总结

Background: Postoperative cognitive dysfunction (POCD) in elderly patients after noncardiac surgery is a common problem.

Therefore,this study was designed to assess POCD after closed-loop coadministration of propofol and remifentanil guided by bispectral index in comparison to intravenous anesthesia in elderly patients undergoing major noncardiac surgery. Methods: After approval of the local ethical committee was obtained, 204 patients (American Society of Anesthesiologists physical status I-III; age, > 55 yr) undergoing surgery (duration, > 1 h) were enrolled into this pospective randomized monocenter study. Patients received anesthesia 3 days after using a neuropsychological test battery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status I-III;
  • undergoing surgery (duration, > 1 h)

排除标准

  • 未提供

研究组 & 干预措施

CLOSED LOOP ANESTHESIA

Experimental

neuropsychological test battery

干预措施: neuropsychological test battery (Procedure)

INTRAVENOUS ANESTHESIA

Experimental

neuropsychological test battery

干预措施: neuropsychological test battery (Procedure)

结局指标

主要结局

the incidence of early POCD in elderly patients (aged 55 yrs or older)

时间窗: 3 DAYS

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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