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

Not Applicable

Not yet recruiting

• Conditions: Carotid Endarterectomy; Cerebral Autoregulation
• Interventions: Other: Cerebral oxygenation index guided hemodynamics management

• 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

• Status Verified: 2024-05
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09
• Study Start: 2024-05-15
• Primary Completion: 2026-11
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_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

Arm && Interventions

Group	Intervention	Description
The autoregulation group	Cerebral oxygenation index guided hemodynamics management	In the autoregulation group, anesthesiologist will maintain that the cerebral oxygen index value below 0.3. If cerebral oxygen index exceeds the threshold, Norepinephrine or Phenylephrine will be infused continuously, or arterial partial pressure of oxygen or arterial partial pressure of carbon dioxide will be adjusted to increase regional cerebral oxygen saturation.

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.

Trial Locations

Locations (1)

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