Middle Cerebral Artery Velocity and Oxygen Saturation of the Brain During Carotid Endarterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients

NCT01149148

Postoperative Cognitive Dysfunction

COMPLETED PHASE3

Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest

NCT02834065

Cognition Disorders

COMPLETED NA

Cerebral Perfusion Variation During Blood Pressure Changes in ICU

NCT05804773

Intensive Care Unit Syndrome

RECRUITING

Cerebral Oximetry and Neurocognitive Functions in Cardiosurgical Patients

NCT00917124

Coronary Artery Disease Postoperative Cognitive Dysfunction Neurological Impairment

COMPLETED NA

The Impact of Non-pulsatile Blood Flow on CO2-Reactivity

NCT03732651

Cerebrovascular Circulation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Investigation of blood flow velocity in the middle cerebral artery and oxygen saturation of the brain bilaterally during carotid endarterectomy carried out in local anesthesia in patients with and without neurological symptoms using transcranial Doppler (TCD) and INVOS monitor.

Zoltán Gyöngyösi Study protocol

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?

Patients and Methods

Outpatient examination, preparation and anesthesia of the patients:

* ECG test
* Echocardiography, if it is necessary due to the cardial status of the patient.
* Indication of surgical intervention provided by the cerebrovascular outpatient clinic, with attached carotid ultrasound and angiography results.

Surgical anesthesia:

* Superficial and deep cervical block with 3.75% ropivacaine (50ml ropivacaine 3.75%) (incase of allergy bupivacaine should be used)
* Securing venous catheter, infusion of Lactated-Ringer or Voluven solution.
* In case of pain topical administration of Lidocaine by the surgeon, intravenous administration of 25-50ug Fentanyl or 1 vial of Algopyrin.

Intraoperative measurements:

* Bilateral transcranial Doppler measurements of the blood flow velocity within the middle cerebral arteries: 1. before local anesthesia, 2. after the onset of local anesthetic, but before skin incision, 3. intraoperatively before clamping the internal carotid artery, 4. one minute after clamping the internal carotid artery, 5. five minutes after clamping the internal carotid artery, 6. fifteen minutes after clamping the internal carotid artery, 7. directly after the restoration of blood flow in the internal carotid artery, 8. postoperatively, 4-6 hours after the intervention.
* Recording mean arterial pressure with each TCD measurement.
* Recording cerebral saturation (INVOS) with each TCD measurement.
* Recording any anti-hypertensive therapy in the postoperative phase.
* Recording heart rate.
* Recording arterial oxygen saturation.
* Recording the patients' neurological status with each TCD measurement and continuous neurological monitoring while the internal carotid artery is clamped.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Oxygen Saturation,MCA Velocity,Intraoperative Neurological Symptoms During Carotid Endarterectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients without neurological symptoms

carotid endarterectomy patients who dont'have any neurological symptoms after carotid clamping

transcranial Doppler (TCD) and INVOS monitor

Intervention Type DEVICE

Bilateral transcranial Doppler measurements of the blood flow velocity within the middle cerebral arteries: 1. before local anesthesia, 2. after the onset of local anesthetic, but before skin incision, 3. intraoperatively before clamping the internal carotid artery, 4. one minute after clamping the internal carotid artery, 5. five minutes after clamping the internal carotid artery, 6. fifteen minutes after clamping the internal carotid artery, 7. directly after the restoration of blood flow in the internal carotid artery, 8. postoperatively, 4-6 hours after the intervention.

patients with neurological symptoms

carotid endarterectomy patients who have new neurological symptoms after carotid clamping

transcranial Doppler (TCD) and INVOS monitor

Intervention Type DEVICE

Bilateral transcranial Doppler measurements of the blood flow velocity within the middle cerebral arteries: 1. before local anesthesia, 2. after the onset of local anesthetic, but before skin incision, 3. intraoperatively before clamping the internal carotid artery, 4. one minute after clamping the internal carotid artery, 5. five minutes after clamping the internal carotid artery, 6. fifteen minutes after clamping the internal carotid artery, 7. directly after the restoration of blood flow in the internal carotid artery, 8. postoperatively, 4-6 hours after the intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

transcranial Doppler (TCD) and INVOS monitor

Bilateral transcranial Doppler measurements of the blood flow velocity within the middle cerebral arteries: 1. before local anesthesia, 2. after the onset of local anesthetic, but before skin incision, 3. intraoperatively before clamping the internal carotid artery, 4. one minute after clamping the internal carotid artery, 5. five minutes after clamping the internal carotid artery, 6. fifteen minutes after clamping the internal carotid artery, 7. directly after the restoration of blood flow in the internal carotid artery, 8. postoperatively, 4-6 hours after the intervention.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No