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

Sponsor
Beijing Municipal Administration of Hospitals (Other)
Overall Status
Recruiting
CT.gov ID
NCT03622515
Collaborator
(none)
220
Enrollment
2
Locations
2
Arms
44.1
Anticipated Duration (Months)
110
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Anesthesia level and cerebral perfusion pressure
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Xuanwu Hospital Capital Medical University
Actual Study Start Date :
Aug 10, 2018
Actual Primary Completion Date :
Apr 12, 2022
Anticipated Study Completion Date :
Apr 12, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xuanwu Hospital Capital Medical University Beijing Beijing China 100053
2 Xuanwu hospital Captial Medical University Beijing Beijing China 100053

Sponsors and Collaborators

  • Beijing Municipal Administration of Hospitals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
XU Na, Principal Investigator, Beijing Municipal Administration of Hospitals
ClinicalTrials.gov Identifier:
NCT03622515
Other Study ID Numbers:
  • ZYLX201818
First Posted:
Aug 9, 2018
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Delirium
Stroke
Ischemic Attack, Transient
Postoperative Cognitive Complications
Cognitive Dysfunction
Anesthetics

Study Results

No Results Posted as of Apr 13, 2022