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 volunteersQualifiers
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
Case-control
Prospective
Treatments tested in this trial
MRI
Diagnostic 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.
Propofol (Astra-Zeneca)
Drugneuroprotection provided by either sevoflurane or propofol using laboratory, clinical and imaging tests and scores such as alderte score during awakening
biomarkers
Diagnostic testBrain biomarkers will be measured prior to artery clampring, 15 minutes after the artery clamping and 15 minutes after the end of surgery
Treatment groups
Trial outcomes
Primary outcomes
new microischemic brain lesions
Number of participants with any silent brain lesions or brain lesions accompanied with cognitive dysfunction postoperatively
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
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: