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

NCT03622515 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2022-04-13

No results posted yet for this study

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.

Conditions

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

Interventions

COMBINATION_PRODUCT

Anesthesia level and cerebral perfusion pressure

Anesthetic dose and blood pressure

Sponsors & Collaborators

  • Beijing Municipal Administration of Hospitals

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-10
Primary Completion
2022-04-12
Completion
2022-04-12

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03622515 on ClinicalTrials.gov