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

Xuanwu Hospital Capital Medical University

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.

Study Overview

• Status: Recruiting
• Conditions: Transient Ischemic Attack; Postoperative Delirium; Postoperative Cognitive Dysfunction; Acute Stroke
• Intervention / Treatment: Combination product: Anesthesia level and cerebral perfusion pressure

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital Capital Medical University
      • Contact: Na XU; Phone Number: 8613810001662; Email: xinan_xu@126.com
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital Captial Medical University
      • Contact: Na XU; Phone Number: 8613810001662; Email: xinan_xu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group S; 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; Anesthetic dose and blood pressure
No Intervention: Group C; Bispectral index (BIS)/Sedline monitoring

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Municipal Administration of Hospitals

Publications and helpful links

General Publications

• Xu N, Li LX, Wang TL, Jiao LQ, Hua Y, Yao DX, Wu J, Ma YH, Tian T, Sun XL. Processed Multiparameter Electroencephalogram-Guided General Anesthesia Management Can Reduce Postoperative Delirium Following Carotid Endarterectomy: A Randomized Clinical Trial. Front Neurol. 2021 Jul 12;12:666814. doi: 10.3389/fneur.2021.666814. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2018
• Primary Completion (Actual): April 12, 2022
• Study Completion (Anticipated): April 12, 2022

Study Registration Dates

• First Submitted: July 29, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Postoperative Complications; Neurocognitive Disorders; Brain Ischemia; Cognition Disorders; Stroke; Ischemic Attack, Transient; Cognitive Dysfunction; Postoperative Cognitive Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: ZYLX201818

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No