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

Not Applicable

• Conditions: Transient Ischemic Attack; Acute Stroke; Postoperative Delirium; Postoperative Cognitive Dysfunction
• Interventions: Combination Product: Anesthesia level and cerebral perfusion pressure

• Registration Number: NCT03622515
• Lead Sponsor: Beijing Municipal Administration of Hospitals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-29
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-09
• Study Start: 2018-08-10
• Status Verified: 2022-04
• Primary Completion: 2022-04-12
• Study Completion: 2022-04-12
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Patients undergoing elective carotid endarterectomy;
2. All those who agree to join the trial and sign the informed consent form;
3. ASAI to III.

Exclusion Criteria

1. Those who refuse to sign the informed consent form;
2. ASA Level IV and above;
3. Unstable angina or acute myocardial infarction within 4 to 6 weeks before surgery, and heart function NYHA III to IV;
4. Those with severe liver and kidney function diseases;
5. 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. ]
6. Preoperative combined anxiety and depression; (SDS or SAS>41 points)
7. Patients with an endotracheal intubation returning to the ICU;
8. severe allergic reactions, major bleeding, etc. during surgery, causing severe fluctuations in hemodynamics;
9. The subject actively requested to withdraw from the study or to be lost to follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group S	Anesthesia level and cerebral perfusion pressure	Sedline monitoring Adjust the depth of anesthesia by adjusting the amount of anesthesia, and adjust the cerebral perfusion pressure by adjusting blood pressure

Primary Outcome Measures

Name	Time	Method
the change from baseline of neurological complications before operation	after operation	Transient ischemic attack, acute stroke, postoperative delirium, postoperative cognitive dysfunction, etc.

Secondary Outcome Measures

Name	Time	Method
the change from baseline of other complications before operation	3 days after operation	acute myocardial infarction, heart failure, arrhythmia, pulmonary infection, atelectasis, acute kidney injury, etc.

Trial Locations

Locations (2)

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

Xuanwu hospital Captial Medical University; 🇨🇳 Beijing, Beijing, China