Clinical trial NCT02665104: Middle Cerebral Artery Velocity and Oxygen Saturation of the Brain During Carotid Endarterectomy
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Oxygen Saturation,MCA Velocity,Intraoperative Neurological Symptoms During Carotid Endarterectomy
Keywords: Cerebral oxygen saturation
TCD
NIRS
Carotid endarterectomy
Lead sponsor: University of Debrecen
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms
timeFrame: 15 month
measure: to determine the changes in cerebral O2 saturation in patient with intraoperative neurological symptoms
timeFrame: 15 month
Secondary outcomes:
measure: 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?
timeFrame: 15 month
Other outcomes:
Locations:
city: Debrecen
country: Hungary
facility: University of Debrecen
state: Hajdú-Bihar
city: Debrecen
country: Hungary
facility: University of Debrecen
Study officials:
affiliation: Hungary University of Debrecen Debrecen, Hungary, 4032
name: Béla Fülesdi, MD,PhD,DSci
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s1078-5884(05)80112-1.
citation: 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.