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

NCT02665104 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2017-03-13

No results posted yet for this study

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?

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of Debrecen

    lead OTHER

Principal Investigators

  • Béla Fülesdi, MD,PhD,DSci · Hungary University of Debrecen Debrecen, Hungary, 4032

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02665104 on ClinicalTrials.gov