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

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.

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Key information

Conditions

Carotid Artery Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Endarterectomy, Carotid Ischemic Cerebrovascular Accident Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Carotid endarterectomy is a surgical procedure with special perioperative and postoperative requirements and potential major adverse events, which can occur rapidly and be life threatening, and compromise the functional and neuropsychiatric integrity of the patient. Stroke is the most frequent major complication both in the intraoperative and immediate postoperative period. The Anesthesiologist is required to ensure adequate cerebral circulation and oxygenation through the close regulation of hemodynamic parameters and the continuous monitoring of cerebral oximetry, with the aim of preventing the occurrence and establishment of cerebral ischemic lesions.

The purpose of this study is to compare two anesthetic drugs (propofol and sevoflurane) during the maintenance of anesthesia in terms of their potential neuroprotective effect, which will be documented through clinical (gross neurological examination and MoCA test), laboratory (neuronal specific enolase NSE and human calcium-binding protein S100B) and imaging (MRI-diffusion) tests, which have proved to have high sensitivity and specificity for the early detection of ischemic brain lesions and cognitive deficits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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
Allergy or contraindication to any anesthetic factor
Patient refusal to participate in the study

Treatment and study plan

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.

Other names: Cognitive function assessment test, brain biomarkers, biomarkers, alderte test

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

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

Primary outcomes

new microischemic brain lesions

Time frame: 24 hours preoperative to 24 hours postoperative

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

Time frame: from 24 hours prior to surgery to 24 hours after the surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

ATHANASIA DIMITRIOS VOULGARI, MD

CONTACT

[email protected]

+306979596731

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Registry information

Official study title

CAROTID ENDATORECTOMY AND GENERAL ANESTHESIA: Assessment and Evaluation of Cerebral Ischemic Damage With Clinical, Laboratory and Imaging Parameters: a Single-center, Prospective, Randomized, Comparative Clinical Study

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 22, 2026
Registry last updated: May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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