Perioperative Changes of Cerebrovascular Autoregulation and Association With Cognitive Function

NCT04101006 | Terminated

• 1 other identifier: PV4771
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Function Abnormal; Anesthesia; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• cognitive failures three months following surgery

  three months after elective surgery

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

screening of patients scheduled for preanesthesia evaluation prior to major non-cardiac/non-vascular surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

• Kahl U, Rademacher C, Harler U, Juilfs N, Pinnschmidt HO, Beck S, Dohrmann T, Zollner C, Fischer M. Intraoperative impaired cerebrovascular autoregulation and delayed neurocognitive recovery after major oncologic surgery: a secondary analysis of pooled data. J Clin Monit Comput. 2022 Jun;36(3):765-773. doi: 10.1007/s10877-021-00706-z. Epub 2021 Apr 15.

  PMID: 33860406 DERIVED

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Study Officials

• Marlene Fischer, MD, PhD

  Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: September 24, 2019
• Study Start: April 14, 2016
• Primary Completion: April 1, 2020
• Study Completion: April 3, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

DE (1)