Perioperative Changes of Cerebrovascular Autoregulation and Association With Cognitive Function
Cerebrovascular Autoregulation During Major Non-cardiac Surgery and Risk for Postoperative Cognitive Dysfunction in Elderly Patients
Cerebral blood flow is tightly regulated to ensure constant cerebral perfusion independently from systemic blood pressure fluctuations. This mechanism is termed cerebrovascular autoregulation and preserves adequate cerebral perfusion in a range between 50 and 150 mmHg of cerebral perfusion pressure. Upper and lower autoregulatory limits may vary individually. Beyond the autoregulatory range the protective autoregulatory response is lost, facilitating cerebral ischemia or hyperemia.
The cerebrovascular response may be altered during general anesthesia, through direct effects of anesthetic agents on the vascular tone, changes of arterial partial pressure of carbon dioxide or the administration of vasoactive substances. The association of perioperative impairment of cerebral autoregulation and postoperative cognitive function has been discussed controversially.
研究概览
详细说明
- continuous monitoring of cerebrovascular autoregulation using the correlation method
- based on near-infrared spectroscopy and invasive blood pressure measurement an index (COx) will be calculated
- autoregulation monitoring from anesthesia induction until emergence from anesthesia
- assessment of preoperative cognitive function during preanesthesia evaluation or on the day before surgery
- assessment of postoperative cognitive function between day 3 and 14 following surgery
- evaluation of subjective cognitive complaints or attention deficits 3 months after surgery
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Hamburg、德国、20246
- Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- elective major non-cardiac/non-vascular surgery
- anticipated surgical duration >120 minutes
- age >= 60 years
- indication for invasive blood pressure measurement
- native German speaker
Exclusion Criteria:
- history of cerebrovascular disease
- preexisting cognitive impairment
- history or presence of neurological disease
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative change of cognitive function from baseline
大体时间：preoperative psychometric evaluation on the day before surgery, postoperative psychometric evaluation between day 3 and 14 after surgery
|
change of cognitive function following surgery compared with preoperative cognitive performance, defined as: z-score <-1.96/>1.96 in two or more neuropsychological tests (California Verbal Learning Test for verbal learning, Grooved Pegboard Test for visual motoric coordination, Digit Span forward task for attention and memory, Trail-Making-Test A and B for executive function) and/or a combined z-score >1.96
|
preoperative psychometric evaluation on the day before surgery, postoperative psychometric evaluation between day 3 and 14 after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
cognitive failures three months following surgery
大体时间：three months after elective surgery
|
Self-assessment of cognitive failures using a validated questionnaire (Cognitive Failures Questionnaire).
The questionnaire evaluates self-reported failures in perception, memory, and motor function.
The questionnaire contains 25 items on a 5-point Likert scale.
Total sum score from 0 (minimum) to 100 (maximum).
|
three months after elective surgery
|
合作者和调查者
调查人员
- 首席研究员：Marlene Fischer, MD, PhD、Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.