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

Postoperative Delirium Clinical Trial

Official title:

Xuanwu Hospital Capital Medical University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03622515
• Other study ID #: ZYLX201818
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2018
• Est. completion date: April 12, 2022

Study information

• Verified date: April 2022
• Source: Beijing Municipal Administration of Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: April 12, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Stroke
• Cognitive Dysfunction
• Delirium
• Ischemic Attack, Transient
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction
• Postoperative Delirium
• Stroke
• Transient Ischemic Attack

Intervention

Combination Product:
• Anesthesia level and cerebral perfusion pressure
Anesthetic dose and blood pressure

Locations

Country	Name	City	State
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	Xuanwu hospital Captial Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Municipal Administration of Hospitals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change from baseline of neurological complications before operation	Transient ischemic attack, acute stroke, postoperative delirium, postoperative cognitive dysfunction, etc.	after operation
Secondary	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