Perioperative Changes of Cerebrovascular Autoregulation and Association With Cognitive Function

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04101006
• Other study ID #: PV4771
• Status: Terminated
• Start date: April 14, 2016
• Est. completion date: April 3, 2020

Study information

• Verified date: August 2020
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: April 3, 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Cognitive Dysfunction
• Cognitive Function Abnormal
• Surgery

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative change of cognitive function from baseline	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
Secondary	cognitive failures three months following 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