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Not yet recruitingNCT07602400Updated May 22, 2026

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

An observational study in Carotid Artery Stenosis, Endarterectomy, Carotid and Ischemic Cerebrovascular Accident, sponsored by University Hospital of Patras. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by University Hospital of Patras · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
160
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Carotid Artery Stenosis
  • Endarterectomy, Carotid
  • Ischemic Cerebrovascular Accident

Keywords

  • carotid endarterectomy
  • MRI brain
  • general anesthesia
  • neuroprotection
  • propofol
  • sevoflurane
03

In context

Carotid Stenosis

364 studies on the registry are indexed under Carotid Stenosis; 85 are open to participants now.

This study's planned enrollment of 160 is close to the median of 176 across 159 observational studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

University Hospital of Patras is the lead sponsor of 43 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 test
  • Patient consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Age ≤ 18 years
  • Presence of major neurological deficits that will not allow neurological evaluation and performance of the 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 to any anesthetic factor
  • Patient refusal to participate in the study
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
160 participants (estimated)
Target follow-up
3 Days
Patient registry
Yes

Groups and cohorts

  • 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

  • Diagnostic testMRI

    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

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

  • Diagnostic testbiomarkers

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

06

What researchers measure

Primary outcomes

  1. new microischemic brain lesions

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

    Time frame: 24 hours preoperative to 24 hours postoperative

  2. 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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07602400
Lead sponsor
University Hospital of Patras
Responsible party
Athanasia Voulgari (MD, Resident of Anesthesiology, Principal Investigator, University Hospital of Patras) — Principal investigator
First posted
May 22, 2026
Start date
May 30, 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
May 22, 2026

Study contacts

ATHANASIA DIMITRIOS VOULGARI, MD
Contact
athanasia13494@hotmail.com
+306979596731
ADAMANTIA ARETHA, PROFESSOR OF ANESTHESIOLOGY
study chair · University Hospital of Patras

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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