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Clinical Trials/NCT04101006
NCT04101006
Terminated
Not Applicable

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

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country78 target enrollmentApril 14, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Function Abnormal
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
78
Locations
1
Primary Endpoint
Postoperative change of cognitive function from baseline
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

* 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

Registry
clinicaltrials.gov
Start Date
April 14, 2016
End Date
April 3, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Postoperative change of cognitive function from baseline

Time Frame: 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

Secondary Outcomes

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

Study Sites (1)

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