NCT06406842

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carotid Endarterectomy
• Cerebral Autoregulation

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-07-08
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2024-05-09
• Last updated: 2025-09-08

Locations

2 sites across 1 country: China