the Research of the Cerebral Protection Effects of Electroencephalogram (SedLine) During Carotid Endarterectomy

Study Overview
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Brief Summary
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Fragile brain is the most common phenomenon seen in the patients undergoing CEA. The patients with fragile brain have a high incidence of postoperative brain dysfunction. This study intends to apply EEG monitoring (Sedline) to CEA to investigate whether EEG monitoring can reduce the incidence of postoperative neurological complications in CEA patients and improve their prognosis. 220 patients with CEA were randomly divided into 2 groups. Group S [Sedline monitoring + Transcranial Doppler (TCD) + regional cerebral oxygen saturation (rS02)，n=110] and group C [Bispectral index (BIS)/Sedline monitoring + TCD +rSO2,n=110], recording intraoperative and postoperative conditions, neuropsychology scale assessment, blood examination and imaging examination. The incidence of postoperative neurological complications was compared between the two groups.

Official Title
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Xuanwu Hospital Capital Medical University

Conditions
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Transient Ischemic Attack, Acute Stroke, Postoperative Delirium, Postoperative Cognitive Dysfunction

Intervention / Treatment
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* Combination Product: Anesthesia level and cerebral perfusion pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective carotid endarterectomy; All those who agree to join the trial and sign the informed consent form; ASAI to III. Exclusion Criteria: Those who refuse to sign the informed consent form; ASA Level IV and above; Unstable angina or acute myocardial infarction within 4 to 6 weeks before surgery, and heart function NYHA III to IV; Those with severe liver and kidney function diseases; Preoperative combined cognitive impairment; [MMSE reference demarcation value: illiterate (uneducated) group ≤ 19 points, primary school (education years ≤ 6 years) group ≤ 22 points, secondary school or above (education years) 6 years) group ≤26 points; MoCA reference demarcation value: illiterate ≤13, primary school ≤19, middle school and above ≤24. ] Preoperative combined anxiety and depression; (SDS or SAS>41 points) Patients with an endotracheal intubation returning to the ICU; severe allergic reactions, major bleeding, etc. during surgery, causing severe fluctuations in hemodynamics; The subject actively requested to withdraw from the study or to be lost to follow-up.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group S<br>Sedline monitoring Adjust the depth of anesthesia by adjusting the amount of anesthesia, and adjust the cerebral perfusion pressure by adjusting blood pressure | Combination Product: Anesthesia level and cerebral perfusion pressure<br>* Anesthetic dose and blood pressure<br>|
| No Intervention: Group C<br>Bispectral index (BIS)/Sedline monitoring | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change from baseline of neurological complications before operation | Transient ischemic attack, acute stroke, postoperative delirium, postoperative cognitive dysfunction, etc. | after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change from baseline of other complications before operation | acute myocardial infarction, heart failure, arrhythmia, pulmonary infection, atelectasis, acute kidney injury, etc. | 3 days after operation |