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

Capital Medical University

Status: Enrolling

Conditions: Cerebral Autoregulation; Carotid Endarterectomy

Treatments: Other: Cerebral oxygenation index guided hemodynamics management

Study type: Interventional

Funder types: Other

Identifiers

NCT06406842

202422047

Details and patient eligibility

About

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.

Enrollment: 560 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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560 participants in 2 patient groups

The autoregulation group

Experimental group

Description:

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.

Treatment:

Other: Cerebral oxygenation index guided hemodynamics management

The routine group

No Intervention group

Description:

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%.