Ireland
--:--IST
Recruiting Not applicable

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

NCT06406842 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-07-08
Last updated
2025-09-08

Condition(s) studied

Carotid EndarterectomyCerebral Autoregulation

Investigational drug(s) / intervention(s)

Cerebral oxygenation index guided hemodynamics management

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Patients scheduled for elective carotid endarterectomy * ASA Ⅱ or Ⅲ * aged 18-80 years old Exclusion Criteria: * preoperative moderate and severe cognitive impairment * preoperative psychotropic medication history within one year * history of neurosurgery * have speech or language impairments

Primary outcome measure(s)

  • 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 sites (2)

FacilityCityRegionStatus
Xuanwu Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Beijing Tian Tan Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06406842 on ClinicalTrials.gov ↗ ← All trials in China