Middle Cerebral Artery Velocity and Oxygen Saturation of the Brain During Carotid Endarterectomy (NCT02665104) | Clinical Trial Compass
UnknownNot Applicable
Middle Cerebral Artery Velocity and Oxygen Saturation of the Brain During Carotid Endarterectomy
Hungary100 participantsStarted 2015-04
Plain-language summary
The primary endpoint of our study is to determine whether neurological symptoms (aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, changes showed by transcranial Doppler or INVOS monitor is more sensitive regarding the symptoms? Secondary endpoint: the degree of change in the measured parameters after the internal carotid artery is clamped, and if there is any difference between the operated and non-operated sides?
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 100 patients awaiting carotid artery endarterectomy carried out in regional anesthesia.
* Age: patients over 18 years.
* Gender: both female and male patients are included in the study.
* Medical equipment: venous catheter, arterial catheter for invasive blood pressure monitoring.
* Bilateral continuous measurement of the middle cerebral arteries with Transcranial Doppler.
* Bilateral continuous measurement of the cerebral saturation with INVOS monitor.
Exclusion Criteria:
* Allergy to ropivacaine, bupivacaine.
* Patients who does not consent to the awake surgery or does not sign the informed consent of the study.
* If the patient is either psychologically or neurologically unsuitable for the awake surgery.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms
Timeframe: 15 month
2
to determine the changes in cerebral O2 saturation in patient with intraoperative neurological symptoms