Perioperative Application of Hemodynamic Management Based on Regional Cerebral Oxygen Saturation Monitoring of Cerebral Autoregulation in Carotid Endarterectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 560
- Locations
- 3
- Primary Endpoint
- The incidence of postoperative cerebral ischemic events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The investigator of control group
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
The incidence of postoperative cerebral ischemic events
Time Frame: 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 Outcomes
- The incidence of postoperative delirium(The first 3 days after surgery)
- Advanced Cognitive Assessment(The day before surgery and postoperative day 4 or 5)
- Pain assessment(At 24, 48, and 72 hours post-surgery)
- Basic Cognition Assessment(The day before surgery and postoperative day 4 or 5)
Investigators
Yuming Peng
Deputy chief of Department of Anesthesiology
Beijing Tiantan Hospital