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

Primary Purpose

Transient Ischemic Attack, Acute Stroke, Postoperative Delirium

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anesthesia level and cerebral perfusion pressure
Sponsored by
Beijing Municipal Administration of Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transient Ischemic Attack

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xuanwu Hospital Capital Medical UniversityRecruiting
  • Xuanwu hospital Captial Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group S

Group C

Arm Description

Sedline monitoring Adjust the depth of anesthesia by adjusting the amount of anesthesia, and adjust the cerebral perfusion pressure by adjusting blood pressure

Bispectral index (BIS)/Sedline monitoring

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the change from baseline of other complications before operation
acute myocardial infarction, heart failure, arrhythmia, pulmonary infection, atelectasis, acute kidney injury, etc.

Full Information

First Posted
July 29, 2018
Last Updated
April 12, 2022
Sponsor
Beijing Municipal Administration of Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT03622515
Brief Title
the Research of the Cerebral Protection Effects of Electroencephalogram (SedLine) During Carotid Endarterectomy
Official Title
Xuanwu Hospital Capital Medical University
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
April 12, 2022 (Actual)
Study Completion Date
April 12, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Municipal Administration of Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Ischemic Attack, Acute Stroke, Postoperative Delirium, Postoperative Cognitive Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group S
Arm Type
Experimental
Arm Description
Sedline monitoring Adjust the depth of anesthesia by adjusting the amount of anesthesia, and adjust the cerebral perfusion pressure by adjusting blood pressure
Arm Title
Group C
Arm Type
No Intervention
Arm Description
Bispectral index (BIS)/Sedline monitoring
Intervention Type
Combination Product
Intervention Name(s)
Anesthesia level and cerebral perfusion pressure
Intervention Description
Anesthetic dose and blood pressure
Primary Outcome Measure Information:
Title
the change from baseline of neurological complications before operation
Description
Transient ischemic attack, acute stroke, postoperative delirium, postoperative cognitive dysfunction, etc.
Time Frame
after operation
Secondary Outcome Measure Information:
Title
the change from baseline of other complications before operation
Description
acute myocardial infarction, heart failure, arrhythmia, pulmonary infection, atelectasis, acute kidney injury, etc.
Time Frame
3 days after operation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Na XU
Phone
8613810001662
Email
xinan_xu@126.com
Facility Name
Xuanwu hospital Captial Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Na XU
Phone
8613810001662
Email
xinan_xu@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34322079
Citation
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.
Results Reference
derived

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

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