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

Investigation of Blood Flow Velocity in the MCA and Oxygen Saturation of the Brain During Carotid Endarterectomy in Local Anesthesia in Patients With and Without Neurological Symptoms Using Transcranial Doppler (TCD) and INVOS Monitor

Sponsors

Lead Sponsor: University of Debrecen

Source University of Debrecen
Brief 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?

Detailed Description

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.

Overall Status Unknown status
Start Date April 2015
Completion Date April 2017
Primary Completion Date April 2017
Study Type Observational
Primary Outcome
Measure Time Frame
to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms 15 month
to determine the changes in cerebral O2 saturation in patient with intraoperative neurological symptoms 15 month
Secondary Outcome
Measure Time Frame
the degree of change in the measured parameters during clamp and declamp after the internal carotid artery is clamped, if there is any difference between the operated and non-operated sides? 15 month
Enrollment 100
Condition
Intervention

Intervention Type: Device

Intervention Name: transcranial Doppler (TCD) and INVOS monitor

Description: 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.

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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.

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Béla Fülesdi, MD,PhD,DSci Principal Investigator Hungary University of Debrecen Debrecen, Hungary, 4032
Overall Contact

Last Name: Zoltán Mr Gyöngyösi, Md

Phone: +3630/2883970

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup:
University of Debrecen | Debrecen, Hajdú-Bihar, 4032, Hungary Recruiting Béla Fülesdi, MD PhD DSci 00 36 52 255 347
University of Debrecen | Debrecen, 4032, Hungary Enrolling by invitation
Location Countries

Hungary

Verification Date

March 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Debrecen

Investigator Full Name: Tamas Vegh, MD

Investigator Title: assistant professor anesthesiologist and intensive care specialist

Keywords
Has Expanded Access No
Arm Group

Label: patients without neurological symptoms

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

Label: patients with neurological symptoms

Description: carotid endarterectomy patients who have new neurological symptoms after carotid clamping

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov