Perioperative Changes of Cerebrovascular Autoregulation and Association With Cognitive Function
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|ClinicalTrials.gov Identifier: NCT04101006|
Recruitment Status : Terminated (recruitment difficulties, high postoperative drop-out rate)
First Posted : September 24, 2019
Last Update Posted : September 1, 2020
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.
|Condition or disease|
|Cognitive Function Abnormal Anesthesia Surgery|
- 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
|Study Type :||Observational|
|Actual Enrollment :||78 participants|
|Official Title:||Cerebrovascular Autoregulation During Major Non-cardiac Surgery and Risk for Postoperative Cognitive Dysfunction in Elderly Patients|
|Actual Study Start Date :||April 14, 2016|
|Actual Primary Completion Date :||April 2020|
|Actual Study Completion Date :||April 3, 2020|
- 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
- cognitive failures three months following surgery [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04101006
|Department of Anesthesiology, University Medical Center Hamburg-Eppendorf|
|Hamburg, Germany, 20246|
|Principal Investigator:||Marlene Fischer, MD, PhD||Department of Anesthesiology, University Medical Center Hamburg-Eppendorf|