Use of Electrophysiological Markers to Predict Post-operative Cognitive Dysfunction

NCT04512989 | Unknown

• 1 other identifier: 542-20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

As the population ages and medical progress is made, many elderly patients that previously would not have been candidates for surgery are now undergoing operations. In this group of older patients, brain dysfunction after anesthesia and surgery, naming post-operative cognitive dysfunction, is well known. Post-operative cognitive dysfunction (POCD) is a term used to describe subtle changes in cognition, such as memory and executive function. The most commonly seen problems are memory impairment and impaired performance on intellectual tasks. In severe cases, it can lead to inability to perform daily living functions. It was previously found that the presence of cognitive dysfunction 3 months after non-cardiac surgery was associated with increased mortality. The mechanisms leading to cognitive impairment after anesthesia and surgery are not yet fully clear. The risk factors are related to patient characteristics, type of operation and anesthetic management. The investigators have recently shown that using different electrophysiological markers, they can monitor attention and perception which might be associated with brain frailty and brain injury. The aims of this proof of concept study are: (i) to find-out whether attention processes might be in association with brain frailty. (ii) to find our whether brain injury which is expressed by interhemispheric synchronization is is associated with POCD; (iii) to find out whether the level of anesthesia, as measured electrophysiological by perception might be linked primary to POCD.

Conditions

Cognitive Dysfunction

Keywords

cognitive dysfunction; EEG

Outcome Measures

Primary Outcomes (3)

• Correlation of Post Operative cognitive dysfunction (POCD) to intra operative EEG changes

  Correlation of post operative cognitive dysfunction as measured by cognitive tests (such as MOCA test) to changes in EEG pattern

  The diagnosis of cognitive dysfunction is assessed post operative on day 7 and compared to baseline pre surgery cognitive function

• Correlation of 45 days POCD to intra operative EEG changes

  Correlation of 45 days POCD, as measured with MOCA test, to intra operative changes in EEG pattern

  The diagnosis of cognitive dysfunction is assessed post operative on day 45 and is compared to baseline pre surgery cognitive function

• Assesing btain frailty

  Correlation of success in pre operative cognitive tests, as measured by MOCA test, to post operative cognitive dysfunction (as measured again by MOCA test)

  The diagnosis of cognitive dysfunction is assessed post operative on day 7 and day 45 and is compared to baseline pre surgery cognitive function

Study Arms (1)

Patients undergoing cardiac surgery

Diagnostic Test: Cognitive assesment using MOCA test

Interventions

Cognitive assesment using MOCA test DIAGNOSTIC_TEST

Cognitive assesment using MOCA test

Patients undergoing cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years or older, ASA 1-4, undergoing elective cardiac surgery (CABG or valve replacement).

You may qualify if:

• Patients 18 years and older undergoing elective cardiac surgery (CABG or valve replacement).

You may not qualify if:

• inability or refusal to provide informed consent,
• significant visual impairment so that the pictures of the cognitive tests could not be interpreted accurately.
• profound dementia or aphasia that interfered with the cognitive assessment.
• inability to speak Hebrew/ Russian or Arabic so that a language barrier was not confused with postoperative cognitive dysfunction.
• Any previously documented major neurologic or psychiatric dysfunction

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

Related Publications (15)

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MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Dana Baron Shahaf

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Baron, MD PhD

CONTACT

+972-4-7772487; dana.barons@gmail.com

Goded Shahaf

CONTACT

godeds@gmail.com

Study Design

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

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 14, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)