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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
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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.


Condition or disease
Cognitive Function Abnormal Anesthesia Surgery

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

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Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
screening of patients scheduled for preanesthesia evaluation prior to major non-cardiac/non-vascular surgery
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

Information from the National Library of Medicine

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


Locations
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Germany
Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Marlene Fischer, MD, PhD Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04101006    
Other Study ID Numbers: PV4771
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders