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ACTIVE NOT RECRUITING
NCT07485933
NA

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

View on ClinicalTrials.gov

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

BEHAVIORAL

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.

DEVICE

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