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

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?

Study Overview

• Status: Unknown
• Conditions: Cerebral Oxygen Saturation,MCA Velocity,Intraoperative Neurological Symptoms During Carotid Endarterectomy
• Intervention / Treatment: Device: transcranial Doppler (TCD) and INVOS monitor

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Zoltán Mr Gyöngyösi, Md; Phone Number: +3630/2883970; Email: zozman77@gmail.com
• Study Contact Backup: Name: Erzsébet Igbonu-nagy, nurse; Phone Number: +3620/3991551; Email: nagyboske@yahoo.com

Study Locations

• Hungary
  • Debrecen, Hungary, 4032
    • Enrolling by invitation
    • University of Debrecen
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Recruiting
      • University of Debrecen
      • Contact: Béla Fülesdi, MD PhD DSci; Phone Number: 00 36 52 255 347
      • Contact: Zoltán Gyöngyösi, md; Phone Number: 00 36 52 255 347

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients without neurological symptoms; carotid endarterectomy patients who dont'have any neurological symptoms after carotid clamping	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.
patients with neurological symptoms; carotid endarterectomy patients who have new neurological symptoms after carotid clamping	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
to determine the changes in cerebral O2 saturation in patient with intraoperative neurological symptoms	Recording cerebral saturation (INVOS) with each measurement.	15 month

Secondary Outcome Measures

Outcome Measure	Measure Description	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?	Recording mean arterial pressure with each TCD measurement. Recording cerebral saturation (INVOS) with each measurement.	15 month

Collaborators and Investigators

• Sponsor: University of Debrecen
• Investigators: Principal Investigator: Béla Fülesdi, MD,PhD,DSci, Hungary University of Debrecen Debrecen, Hungary, 4032

Publications and helpful links

General Publications

• 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. doi: 10.1016/s1078-5884(05)80112-1.
• 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.2013.07.007. Epub 2013 Aug 21.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Carotid endarterectomy; NIRS; Cerebral oxygen saturation; TCD
• Other Study ID Numbers: DE RKEB/IKEB:4364/2015; 094579/2015/OTIG (Other Identifier: Health Registration and Training Center Department of Medical Devices)