跳至主要内容
临床试验/NCT04101006
NCT04101006终止不适用

Cerebrovascular Autoregulation During Major Non-cardiac Surgery and Risk for Postoperative Cognitive Dysfunction in Elderly Patients

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2016年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
78
试验地点
1
主要终点
Postoperative change of cognitive function from baseline

研究概览

简要总结

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.

详细描述

  • 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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective major non-cardiac/non-vascular surgery
  • anticipated surgical duration >120 minutes
  • age >= 60 years
  • indication for invasive blood pressure measurement
  • native German speaker

排除标准

  • history of cerebrovascular disease
  • preexisting cognitive impairment
  • history or presence of neurological disease

结局指标

主要结局

Postoperative change of cognitive function from baseline

时间窗: 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

次要结局

  • cognitive failures three months following surgery(three months after elective surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验