Perioperative Changes of Cerebrovascular Autoregulation and Association With Cognitive Function

NCT ID: NCT04101006

Last Updated: 2020-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-14

Study Completion Date

2020-04-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cognitive Function Abnormal Anesthesia Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marlene Fischer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33860406 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PV4771

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Parameters of Cerebral Perfusion
NCT02806492 COMPLETED NA
Brain Autoregulation Research Study
NCT07221721 NOT_YET_RECRUITING NA