Clinical trial NCT04101006: Perioperative Changes of Cerebrovascular Autoregulation and Association With Cognitive Function
Official title: Cerebrovascular Autoregulation During Major Non-cardiac Surgery and Risk for Postoperative Cognitive Dysfunction in Elderly Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cognitive Function Abnormal
Anesthesia
Surgery
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 78
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: screening of patients scheduled for preanesthesia evaluation prior to major non-cardiac/non-vascular surgery

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

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

Primary outcomes:
measure: Postoperative change of cognitive function from baseline
timeFrame: preoperative psychometric evaluation on the day before surgery, postoperative psychometric evaluation between day 3 and 14 after surgery
Secondary outcomes:
measure: cognitive failures three months following surgery
timeFrame: three months after elective surgery
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
name: Marlene Fischer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.