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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital of Patras

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

  • 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

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: group propofol3 interventions
Group B: group sevoflurane3 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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