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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The autoregulation group | Experimental | 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. |
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| The routine group | No Intervention | In the routine group, the screen of the collection monitor will be covered by a black cloth . Anesthesiologist will not have access to the patient's cerebral oxygen index value. Anesthesiologist will strive to maintain mean arterial pressure within a ± 20% range of their baseline mean arterial pressure. Outside of this range, the same vasoactive drugs will be employed for modulation. Additionally, anaesthesiologists will maintain PaCO₂ within the range of 35-45 mmHg and set the fraction of inspired oxygen at 50%. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebral oxygenation index guided hemodynamics management | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postoperative cerebral ischemic events | 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. | postoperative 3 day |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postoperative delirium | The incidence and severity of postoperative delirium will be assessed during the first 3 days after surgery. Delirium will be assessed twice daily between 8:00-10:00 and 18:00-20:00 in ward patients with the Richmond Agitation Sedation Scale (RASS) and the 3 min diagnostic interview for CAM (3D-CAM). ICU patients will be similarly assessed with RASS and the confusion assessment method for ICU (CAM-ICU). Any positive 3D-CAM or CAM-ICU assessment will be considered evidence of delirium. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuming MD Peng, Ph.D | Contact | 8610-59976658 | florapym766@163.com | |
| Yuming MD Peng, Ph.D | Contact | 861059976658 | florapym766@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuming MD Peng, Ph.D | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40537236 | Derived | 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. |
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The investigator of control group
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| The first 3 days after surgery |
| Basic Cognition Assessment | Postoperative basic cognitive function will be assessed by Mini-mental State Examination. This will be rated on a scale from 0 to 30, higher cores corresponded to higher levels of cognitive function. | The day before surgery and postoperative day 4 or 5 |
| Advanced Cognitive Assessment | Postoperative basic cognitive function will be assessed by Montreal Cognitive Assessment-Basic Examination. This will be rated on a scale from 0 to 30, higher cores corresponded to higher levels of cognitive function. | The day before surgery and postoperative day 4 or 5 |
| Pain assessment | Pain scores will be recorded at rest and during movement . The pain was rated on a scale from 0 to 10, where 0 indicated no pain and 10 indicated the worst possible pain. Higher scores corresponded to higher levels of pain. | At 24, 48, and 72 hours post-surgery |
| Beijing Tian Tan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100070 | China |
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