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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

NCT07485933 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

  • Carotid Arteriosclerosis
  • Near Infrared Spectroscopy

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.

Sponsors & Collaborators

  • Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2027-12-01
Completion
2027-12-01

Countries

  • Serbia

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 NCT07485933 on ClinicalTrials.gov