RecruitingNot ApplicableNCT06406842

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

Perioperative Application of Hemodynamic Management Based on Regional Cerebral Oxygen Saturation Monitoring of Cerebral Autoregulation in Carotid Endarterectomy

Sponsor

Beijing Tiantan Hospital

Enrollment

560 participants

Start Date

Jul 8, 2024

Study Type

INTERVENTIONAL

Conditions

Carotid Endarterectomy Cerebral Autoregulation

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This observational study looks at whether monitoring oxygen levels in the brain during carotid artery surgery (a procedure to clear blockages in neck arteries) can help predict thinking and memory problems after the operation. **You may be eligible if...** - You are between 18 and 80 years old - You are scheduled for planned (non-emergency) carotid endarterectomy surgery - You are classified as ASA physical status II or III (mild to moderate health issues) **You may NOT be eligible if...** - You have moderate or severe cognitive impairment before surgery - You have taken psychiatric medications within the past year - You have had previous brain or nerve surgery - You have speech or language impairments that would affect testing Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCerebral 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.