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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02665104
• Other study ID #: DE RKEB/IKEB:4364/2015
• Secondary ID: 094579/2015/OTIG
• Status: Recruiting
• Phase: N/A
• First received: January 13, 2016
• Last updated: March 8, 2017
• Start date: April 2015
• Est. completion date: April 2017

Study information

• Verified date: March 2017
• Source: University of Debrecen
• Contact: Zoltán Mr Gyöngyösi, Md
• Phone: +3630/2883970
• Email: zozman77[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Hungary	University of Debrecen	Debrecen	Hajdú-Bihar
Hungary	University of Debrecen	Debrecen

Sponsors (1)

Lead Sponsor	Collaborator
University of Debrecen

Country where clinical trial is conducted

Hungary, 

References & Publications (2)

Pennekamp CW, Immink RV, den Ruijter HM, Kappelle LJ, Bots ML, Buhre WF, Moll FL, de Borst GJ. Near-infrared spectroscopy to indicate selective shunt use during carotid endarterectomy. Eur J Vasc Endovasc Surg. 2013 Oct;46(4):397-403. doi: 10.1016/j.ejvs. — View Citation

Williams IM, Mead G, Picton AJ, Farrell A, Mortimer AJ, McCollum CN. The influence of contralateral carotid stenosis and occlusion on cerebral oxygen saturation during carotid artery surgery. Eur J Vasc Endovasc Surg. 1995 Aug;10(2):198-206. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms	(aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms; Recording mean arterial flow velocity with each TCD measurement.	15 month
Primary	to determine the changes in cerebral O2 saturation in patient with intraoperative neurological symptoms	Recording cerebral saturation (INVOS) with each measurement.	15 month
Secondary	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?	Recording mean arterial pressure with each TCD measurement. Recording cerebral saturation (INVOS) with each measurement.	15 month