Association Between Local Cerebral Oxygenation Monitoring and Postoperative Stroke in Carotid Endarterectomy

Not Applicable

Recruiting

• Conditions: Carotid Endarterectomy; Cerebral Autoregulation

• Registration Number: NCT06406842
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

Carotid endarterectomy (CEA) is used to treat symptomatic extracranial internal carotid artery stenosis. The occult stroke of CEA patients evaluated by magnetic resonance imaging 3 days after operation was as high as 17%. Cerebral blood flow autoregulation (CA) is the ability of the brain to maintain the relative stability of cerebral blood flow, and cerebral oxygen index (Cox) can be used to reflect CA. A negative value of cerebral oxygen index or a value near zero indicates that CA is complete, and cerebral oxygen index close to 1 indicates that CA has lost its ability. In theory, real-time monitoring of CA function by cerebral oxygen index and individualized management strategy with this goal can potentially reduce perioperative ischemic brain injury. The purpose of this study is to explore the influence of the management strategy of monitoring CA function based on regional cerebral oxygen saturation on the postoperative neurological complications of CEA patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-09
• Study Start: 2024-07-08
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-02
• Last Update Posted: 2025-09-08
• Primary Completion: 2026-11
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

• 1. Patients scheduled for carotid endarterectomy, 2.aged 18-80 years old, 3. patients or their legally authorized representatives consented to participate in this trial and signed the informed consent form.

Exclusion Criteria

• 1. Patients with severe cognitive impairment who are unable to undergo follow-up assessments , 2.history of psychiatric medication use, 3.history of intracranial surgery; impaired hearing or vision, and language disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative cerebral ischemic events	postoperative 3 day	Our primary outcome will be the incidence of new ischemic brain injury within 3 days after surgery, defined as new infarct focus detected by magnetic resonance imaging diffusion-weighted imaging or computed tomography, with or without new-onset limb weakness, paresthesia, or language abnormalities. Diffusion-weighted imaging sequences will be used at each scan to detect acute ischemic brain lesions.

Secondary Outcome Measures

Name	Time	Method
The incidence of postoperative delirium	The first 3 days after surgery	The incidence and severity of postoperative delirium will be assessed during the first 3 days after surgery. Delirium will be assessed twice daily between 8:00-10:00 and 18:00-20:00 in ward patients with the Richmond Agitation Sedation Scale (RASS) and the 3 min diagnostic interview for CAM (3D-CAM). ICU patients will be similarly assessed with RASS and the confusion assessment method for ICU (CAM-ICU). Any positive 3D-CAM or CAM-ICU assessment will be considered evidence of delirium.
Advanced Cognitive Assessment	The day before surgery and postoperative day 4 or 5	Postoperative basic cognitive function will be assessed by Montreal Cognitive Assessment-Basic Examination. This will be rated on a scale from 0 to 30, higher cores corresponded to higher levels of cognitive function.
Pain assessment	At 24, 48, and 72 hours post-surgery	Pain scores will be recorded at rest and during movement . The pain was rated on a scale from 0 to 10, where 0 indicated no pain and 10 indicated the worst possible pain. Higher scores corresponded to higher levels of pain.
Basic Cognition Assessment	The day before surgery and postoperative day 4 or 5	Postoperative basic cognitive function will be assessed by Mini-mental State Examination. This will be rated on a scale from 0 to 30, higher cores corresponded to higher levels of cognitive function.

Trial Locations

Locations (2)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing Municipality, China

Beijing Tian Tan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing Municipality, China