CAROTID ENDATORECTOMY AND GENERAL ANESTHESIA: Assessment and Evaluation of Cerebral Ischemic Damage With Clinical, Laboratory and Imaging Parameters

NCT07602400 | Not Yet Recruiting FDA Drug FDA Device

• 1 other identifier: 379/7-10-2025
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is aiming to provide us with information about the neuroprotective effect of two commonly used anesthetic drugs, during carotid endarterectomy. A day before sugery, a brain MRI will be performed as well as a cognitive function assessment test. The day of the surgery each patient will receive anesthesia either by using intravenous anesthetic drug or an inhalation agent and during the intraoperative period, the Anesthesiologist will draw a small amount of blood in three different times in order to measure brain biomarkers. A day after the surgery, a second brain MRI will be performed as well as a second cognitive function assessment test and their results will be compared to the preoperative ones. The study will focus on whether there is a higher incidence of microischemic brain lesions shown in imaging tests or whether cognitive function is impaired postoperative or whether brain biomarkers indicating brain damage are elevayed with any of these drugs and thus conclude which one shows or not a neuroprotective effect, with the condition that no change in the regular anesthesia management was made and no danger was imposed on the patient.

Conditions

Carotid Artery Stenosis; Endarterectomy, Carotid; Ischemic Cerebrovascular Accident

Keywords

carotid endarterectomy; MRI brain; general anesthesia; neuroprotection; propofol; sevoflurane

Outcome Measures

Primary Outcomes (2)

• new microischemic brain lesions

  Number of participants with any silent brain lesions or brain lesions accompanied with cognitive dysfunction postoperatively

  24 hours preoperative to 24 hours postoperative

• neuroprotective effect

  The group of patients that has the fewer adverse events as assessed clinically or with laboratory and imaging tests will be considered to receive the most neuroprotective anesthetic agent

  from 24 hours prior to surgery to 24 hours after the surgery

Study Arms (2)

group propofol

Anesthesia will be preserved using propofol in the patients of this group

Diagnostic Test: MRI; Drug: Propofol (Astra-Zeneca); Diagnostic Test: biomarkers

group sevoflurane

Anesthesia will be preserved using sevoflurane in the patients of this group

Diagnostic Test: MRI; Drug: Propofol (Astra-Zeneca); Diagnostic Test: biomarkers

Interventions

MRI DIAGNOSTIC_TEST

MRI diffusion and cognitive function assessment tests will be performed prior to surgery and postoperatively 24 hours after the end of the surgery so as any new brain lesion to be detected.

Also known as: Cognitive function assessment test, brain biomarkers, biomarkers, alderte test

group propofol; group sevoflurane

Propofol (Astra-Zeneca) DRUG

neuroprotection provided by either sevoflurane or propofol using laboratory, clinical and imaging tests and scores such as alderte score during awakening

group propofol; group sevoflurane

biomarkers DIAGNOSTIC_TEST

Brain biomarkers will be measured prior to artery clampring, 15 minutes after the artery clamping and 15 minutes after the end of surgery

group propofol; group sevoflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are 18 or over 18 years old and come to the hospital for planned carotid endarterectomy and do not have major neurological deficits prior to surgery

You may qualify if:

• Age ≥ 18 years
• ASA 1-4
• For planned carotid endarterectomy
• Absence of major established neurological deficits that would not allow neurological evaluation and performance of the MoCA test
• Patient consent to participate in the study

You may not qualify if:

• Age ≤ 18 years
• Presence of major neurological deficits that will not allow neurological evaluation and performance of the MoCA test
• Claustrophobia and inability to enter the MRI scanner
• Cochlear implants
• Intracranial vascular clips
• Neurostimulation systems
• Pacemaker incompatible for MRI
• Small cell and non-small cell lung cancer
• Neuroendocrine tumors
• Melanoma
• Seminoma
• Teratoma
• Malignant pheochromocytoma
• CNS or NM diseases
• Schizophrenia

Sponsors & Collaborators

• University Hospital of Patras: lead

MeSH Terms

Conditions

Carotid Stenosis; Ischemic Stroke

Interventions

Environmental Biomarkers; Propofol

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke

Intervention Hierarchy (Ancestors)

Biomarkers; Biological Factors; Biological Phenomena; Environmental Monitoring; Environmental Exposure; Environmental Pollution; Public Health; Environment and Public Health; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• ADAMANTIA ARETHA, PROFESSOR OF ANESTHESIOLOGY

  University Hospital of Patras

  STUDY CHAIR

Central Study Contacts

ATHANASIA DIMITRIOS VOULGARI, MD

CONTACT

+306979596731; athanasia13494@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Resident of Anesthesiology, Principal Investigator

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share