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临床试验/NCT02382445
NCT02382445已完成不适用

Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction by a Higher Load of Neurotrophic Drugs

Heidelberg University1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
138
试验地点
1
主要终点
Postoperative cognition and mental capacity of elderlies following major surgery

研究概览

简要总结

Anesthetics and anesthesia are suspicious to induce dementia or aggravate preexistent cognitive deficits with or without evoking postoperative delirium. In animal trials various anesthetics induce increased levels of misfolded amyloid beta and protein tau, the molecular substance of pathophysiologic brain tissues of demented patients. The amount of those markers seems to correlate well with the degree of dementia [1]. In contradiction, a single study indicates that the incidence of postoperative cognitive deficit (POCD) decreases if hypnotic depth is deep [2]. Unfortunately the study did not sum up the amount of anesthetic drug load, since this would have clarified if the amount of anesthetics used is associated to POCD and dementia. Another possibility is that stress and noxious stimulation induced by light anesthesia results in POCD, whereas deep anesthesia protects from it or inhibits implicit memory.

The investigators' prospective randomized trial is underway to verify the impact of anesthetics and narcotic depth upon grade of dementia and incidence of early postoperative cognitive dysfunction on postoperative day 1 as well as the incidence of delirium within a 90 day period.

The investigators' hypothesis is that the incidence of POCD and delirium and the degree of early cognitive dysfunction is less when anesthetic and vasoactive drug load is less in the BIS- guided anesthesia group with the superficial but sufficient anesthesia level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults older than 70 years
  • major surgery ( spine, orthopedic, urologic, gynecology, abdominal)

排除标准

  • adults younger than 71 years
  • major blood loss surgery
  • allergy to soja oil, nuts, other ingredients of propofol
  • patient wants to have spinal or regional anesthesia only

研究组 & 干预措施

Anesthesia depth monitor

Experimental

Anesthesia depth is aimed to be between BIS 50-60

干预措施: Anesthesia depth monitor (Device)

Anesthesia depth monitor

Experimental

Anesthesia depth is aimed to be between BIS 50-60

干预措施: propofol and sevoflurane (Drug)

Control group

Sham Comparator

Anesthesia depth is monitored but blinded to the anesthesiologist

干预措施: Sham control (Device)

Control group

Sham Comparator

Anesthesia depth is monitored but blinded to the anesthesiologist

干预措施: propofol and sevoflurane (Drug)

结局指标

主要结局

Postoperative cognition and mental capacity of elderlies following major surgery

时间窗: One day after surgery

Mini Mental State Test (MMSE) and automated Memory and Attention Test (MAT) were performed on the day before and after the surgery. The MAT is a validated computerized test for the discrimination of short and long time memory, for visual and auditory comprehension and attention capacity.

次要结局

  • Incidence of mental and other complications (serious adverse events)(90 postoperative days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Frietsch

Prof. Dr. med. Thomas Frietsch

Universitätsmedizin Mannheim

研究点 (1)

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