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Comparison of Cerebral Oximetry and Neurological Status Testing in the Awake Patient in the Detection of Cerebral Ischemia During Carotid Endarterectomy
Sponsor: Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia
Summary
This randomized controlled study compares two methods of intraoperative cerebral ischemia monitoring during carotid endarterectomy performed under regional anesthesia: neurological testing in the awake patient and near-infrared spectroscopy (NIRS). The study aims to determine whether NIRS is equivalent to awake neurological testing in detecting cerebral ischemia during carotid artery clamping and in guiding the use of an intraluminal shunt.
Official title: Comparison of Cerebral Oximetry and Neurological Status Testing in the Awake Patient in the Detection of Cerebral Ischemia During Carotid Endarterectomy - a Randomized Controlled Trial
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2025-12-22
Completion Date
2027-12-01
Last Updated
2026-03-20
Healthy Volunteers
No
Interventions
Awake Neurological Testing
Neurological monitoring during carotid endarterectomy under regional anesthesia. Intraluminal shunt placement is guided by verbal communication and contralateral hand motor testing to detect cerebral ischemia. NIRS monitoring is recorded but not used to guide shunt placement.
Near-Infrared Spectroscopy (NIRS) Monitoring
Continuous monitoring of regional cerebral oxygen saturation during carotid endarterectomy under regional anesthesia. Intraluminal shunt placement is guided by a decrease of more than 20% from baseline NIRS values. Awake neurological testing is recorded but not used for shunt decisions.
Locations (1)
Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia
Belgrade, Serbia