Carotid Artery StenosisNCT07602400
CAROTID ENDATORECTOMY AND GENERAL ANESTHESIA: Assessment and Evaluation of Cerebral Ischemic Damage With Clinical, Laboratory and Imaging Parameters
An observational study of Carotid Artery Stenosis and Endarterectomy, Carotid, run by University Hospital of Patras.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis, Endarterectomy, Carotid, Ischemic Cerebrovascular Accident
- What is being tested?
- MRI, Propofol (Astra-Zeneca) and biomarkers
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2026to Dec 2027
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- MRI, Propofol (Astra-Zeneca), biomarkers
- Keywords
- carotid endarterectomy, MRI brain, general anesthesia, neuroprotection, propofol, sevoflurane
- Medical subject headings
- Carotid Stenosis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Also called Cognitive function assessment test, brain biomarkers, biomarkers, alderte 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.
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
biomarkersDiagnostic test
Brain biomarkers will be measured prior to artery clampring, 15 minutes after the artery clamping and 15 minutes after the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| group propofol | Anesthesia will be preserved using propofol in the patients of this group Receives: Diagnostic Test: MRI; Drug: Propofol (Astra-Zeneca); Diagnostic Test: biomarkers | |
| group sevoflurane | Anesthesia will be preserved using sevoflurane in the patients of this group Receives: Diagnostic Test: MRI; Drug: Propofol (Astra-Zeneca); Diagnostic Test: biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
new microischemic brain lesions
Number of participants with any silent brain lesions or brain lesions accompanied with cognitive dysfunction postoperatively
Measured: 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
Measured: from 24 hours prior to surgery to 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start30 May 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athanasia Voulgari, University Hospital of Patras
- Investigators
- ADAMANTIA ARETHA, PROFESSOR OF ANESTHESIOLOGY, Study chair, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602400
- Sponsor's protocol ID
- 379/7-10-2025
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07602400
- Acronym / sponsor ID
- 379/7-10-2025
- Keywords
- carotid endarterectomy, MRI brain, general anesthesia, neuroprotection, propofol, sevoflurane
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group propofol | – | Diagnostic Test: MRI, Drug: Propofol (Astra-Zeneca), Diagnostic Test: biomarkersAnesthesia will be preserved using propofol in the patients of this group |
| group sevoflurane | – | Diagnostic Test: MRI, Drug: Propofol (Astra-Zeneca), Diagnostic Test: biomarkersAnesthesia will be preserved using sevoflurane in the patients of this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: Cognitive function assessment test, brain biomarkers, biomarkers, alderte testMRI 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. | Diagnostic test | group propofol, group sevoflurane |
| Propofol (Astra-Zeneca)neuroprotection provided by either sevoflurane or propofol using laboratory, clinical and imaging tests and scores such as alderte score during awakening | Drug | group propofol, group sevoflurane |
| biomarkersBrain biomarkers will be measured prior to artery clampring, 15 minutes after the artery clamping and 15 minutes after the end of surgery | Diagnostic test | group propofol, group sevoflurane |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ADAMANTIA ARETHA, PROFESSOR OF ANESTHESIOLOGY study chair
University Hospital of Patras
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis and Endarterectomy, Carotid, run by University Hospital of Patras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ATHANASIA DIMITRIOS VOULGARI, MD (+306979596731, athanasia13494@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
new microischemic brain lesions (time frame: 24 hours preoperative to 24 hours postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.