Association Between Local Cerebral Oxygenation Monitoring and Postoperative Stroke in Carotid Endarterectomy
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cerebral oxygenation index guided hemodynamics management.
- Who it may be relevant to
- Registry conditions: Carotid Endarterectomy, Cerebral Autoregulation. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Perioperative Application of Hemodynamic Management Based on Regional Cerebral Oxygen Saturation Monitoring of Cerebral Autoregulation in Carotid Endarterectomy
Overview
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.
Interventions
- 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.
Primary outcome measures
- The incidence of postoperative cerebral ischemic events [Time frame: postoperative 3 day]
Secondary outcome measures (4)
- The incidence of postoperative delirium [Time frame: The first 3 days after surgery]
- Basic Cognition Assessment [Time frame: The day before surgery and postoperative day 4 or 5]
- Advanced Cognitive Assessment [Time frame: The day before surgery and postoperative day 4 or 5]
- Pain assessment [Time frame: At 24, 48, and 72 hours post-surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 2 centers
- Xuanwu Hospital, Capital Medical University — Beijing
- Beijing Tian Tan Hospital, Capital Medical University — Beijing
Publications
- Li M, Yin X, Liang C, Tao C, Yan Q, Zeng M, Li S, Sessler DI, Wang R, Zhao L, Peng Y. Effect of perioperative haemodynamic management based on cerebral autoregulation monitored by Cerebral Oximetry Index during carotid endarterectomy: protocol of a randomised trial. BMJ Open. 2025 Jun 19;15(6):e094156. doi: 10.1136/bmjopen-2024-094156. PMID 40537236
Identifiers
NCT: NCT06406842 · 202422047