Assessment of Cognitive Function in Patients Undergoing Elective Carotid Endarterectomy
Assessment of cognitive function in patients undergoing elective carotid endarterectomy
Classical treatment for ICA stenosis is carotid endarterectomy (CEA), which has been proven effective in preventing future stroke as well as improving cerebral perfusion. However, the influence of CEA on cognition is less defined, it remains unclear whether CEA can improve cognitive function. A change in cognition is one of the most threatening diseases of recent years, cognitive impairment significantly impacts patients, families, and healthcare system.
The difference in the cognitive outcome may be accounted for microembolic events and adverse changes in haemodynamic circumstances.
The aim of our study is to identify those factors what may have role in the postoperative cognitive decline.
The study was approved by the Ethical Committee of the university ( SE RKEB: 17/2019) and written informed consent will be obtained from all patients.
The investigators intend to enroll patient aged more than 18 years undergoing elective carotid endarterectomy at our hospital ( Semmelweis University Heart and Vascular Center). Exclusion criterion included young age (less than 18 years), incapacity and urgent surgery. The investigators would like to register at least 100-150 patients in our study.
Most relevant anamnestic dates, the results of the laboratory and radiological reports will be recorded. Cognitive functions will be assessed one day before, one day and six month after the surgery using MMSE and a questionnaire called Frailty to characterize beside cognitive function the physiological reserve of the patients too.
The investigators manage patients undergoing carotid endarterectomy with general anaesthesia, using inhaled or total intravenous agents.
During the operation the investigators record beside the routine monitoring (intraarterial blood pressure, ECG, oxygen saturation, EtCO2, MAC) the cerebral tissue oxygen saturation using a near-infrared cerebral oximeter (Invos Cerebral/Somatic Oximeter) and the activity of the brain using GE Entropy Module.
The investigators would like to register the changes in the haemodynamic and cerebral condition and compare these results against the clinical outcome and the changes of the questionnaires.
Statistical analyses will be performed using Statistical Package for the Social Sciences.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andrea Szekely MD, PhD, DEAA Associate Professor of Anesthesia
- Phone Number: +36203304584
- Email: andi_szekely@yahoo.com
Study Contact Backup
- Name: Ágnes Sándor MD
- Phone Number: +36208250738
- Email: sandoragnesdora@gmail.com
Study Locations
-
-
Pest
-
Budapest, Pest, Hungary, 1122
- Recruiting
- Heart and Vascular Center
-
Contact:
- Andrea Szekely MD, PhD, DEAA Associate Professor of Anesthesia
- Phone Number: +36-20-3304584
- Email: andi_szekely@yahoo.com
-
Contact:
- Ágnes Sándor MD
- Phone Number: +36308250738
- Email: sandoragnesdora@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- aged more than 18 years, undergoing elective carotid endarterectomy
Exclusion Criteria:
- younger than 18 years, incapacity, urgent surgery, lack of consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Surgical treatment of carotid endarterectomy
The change in the cognitive function will be assessed in all patient undergoing carotid endarterectomy.
|
Surgical treatment of ICA stenosis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in cognitive function after carotid endarterectomy
Time Frame: six months
|
Change in MMSE score after the carotid endarterectomy compared to baseline.
|
six months
|
|
Change in cognitive function after carotid endarterectomy
Time Frame: six months
|
Change in Montreal Cognitive Assessment test after the endarterectomy compared to baseline.
|
six months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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