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临床试验/NCT02045004
NCT02045004已完成不适用

Association Between Changes in Cerebral Gray Matter Volume and Postoperative Cognitive Dysfunction in Elderly Patients Following Sevoflurane Anesthesia (POCD-MRI)

Nicolai Goettel1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Cerebral gray matter volume

研究概览

简要总结

Despite an ongoing controversy in the scientific literature, the link between anesthesia and dementia and/or cerebral atrophy remains unclear. Recent retrospective data suggests an association of surgery with a reduction in brain volume. With the present prospective cohort study, we would like to reproduce and verify these results, and investigate a possible association with the postoperative cognitive performance.

We will measure cerebral gray matter volumes in elderly patients before, 3 and 12 months after major non-cardiac surgery and determine cognitive functions at the same time.

Study hypothesis:

  1. Surgery under general anesthesia in elderly patients is associated with a loss of gray matter.
  2. The degree of cognitive dysfunction is associated with the loss of grey matter in brain areas relevant for cognitive functions.

详细描述

Background:

Anesthesia care for elective surgery of patients that are in their seventies or eighties is an ever-growing entity in clinical practice, given the demographic development in many countries of the Western world. Cognitive decline of variable degree is frequently observed after major surgery in elderly patients. A potential association between anesthesia and the development of dementia and brain atrophy in elderly patients is controversial. However, it is not uncommon that during preoperative visits by the anesthesiologist, patients express fear to suffer some sort of cognitive decline after the operation, and raise concerns about psychological or neurological long-term adverse effects (e.g. memory loss) related to anesthesia. Clinicians have identified this problem decades ago, and are adding postoperative cognitive dysfunction (POCD) to the list of frequent complications of anesthesia in elderly patients; yet, there is a lack of prospective clinical data and poor understanding of the pathophysiology of POCD, and no preventive strategy or treatment has been described so far.

One study reported an incidence of postoperative cognitive dysfunction (POCD) of 41% in surgical patients 60 years of age, or older. In a previous study conducted by our group, as many as 47% of patients over 65 years presented with POCD one week after surgery. In many patients, this is a transient problem, but some patients retain permanent deficits, with increased mortality and important consequences on the socioeconomic situation. An association between surgery and long-term cognitive decline has not been established yet; however, patients who develop postoperative delirium (a transient, but particularly severe form of POCD) have an increased risk of developing dementia in the years following surgery. However, in a cohort follow-up study, the diagnosis of POCD itself did not represent a significant risk factor for dementia. The pathophysiology of postoperative cognitive decline remains unclear. However, studies in animals have shown that the systemic inflammatory response elicited by the surgical procedure is associated with microglial activation and postoperative cognitive impairment. Furthermore, volatile anesthetics have been shown to be neurotoxic in cell cultures, and in some animal experiments exposure to clinical concentrations of volatile anesthetics was associated with postoperative cognitive decline. A recent retrospective analysis of cohort data suggests that surgery may be associated with a decrease in brain volume in patients. However, due to methodological limitations in this study, no analysis of a potential link between atrophy and cognitive functions was made.

Study Design:

Prospective cohort study

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Age ≥ 65 years
  • •Elective major surgery
  • •Planned general anesthesia

排除标准

  • •Cardiac surgery
  • •Neurosurgery including carotid endarterectomy
  • •Preoperative Mini Mental State (MMS) Examination Score < 24
  • •Previous pathological neuroimaging (if available)
  • •History of cerebral or cerebrovascular pathology
  • •Chronic use of psychiatric medication
  • •Alcohol or substance abuse
  • •A history of chronic pain unrelated to the planned surgery
  • •Any contraindication for MRI (e.g. pacemakers and other MR-incompatible metal implants)
  • •Claustrophobia
  • •Lack of informed consent

结局指标

主要结局

Cerebral gray matter volume

时间窗: Preoperatively, at 3 month and 12 month postoperatively

Hippocampal volume is specifically assessed.

次要结局

  • Cognitive function(Preoperatively, at 7 days, 3 month and 12 month postoperatively)

研究者

发起方
Nicolai Goettel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nicolai Goettel

MD, Staff Anesthesiologist

University Hospital, Basel, Switzerland

研究点 (1)

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