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EEG - Guided Anesthetic Care and Postoperative Delirium

NCT03330236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1560

Last updated 2020-11-09

Study results available
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Summary

The study is a prospective, double blinded, randomized and controlled parallel trial to investigate the effect of the anesthetic care guided by EEG monitor (SedLine) on postoperative delirium. EMODIPOD = Electroencephalography Monitoring tO Decrease the Incidence of PostOperative Delirium

Conditions

  • Delirium
  • Emergence Delirium
  • Anesthesia, General
  • Electroencephalography
  • Laparoscopy
  • Surgical Procedures, Operative

Interventions

DEVICE

Anesthetic "depth" management

The propofol and remifentanil infusion rates will be adjusted to maintain the spectral edge frequency (SEF) value at 10-15 and the patient state index (PSI) value at 25-50 based on the SedLine EEG Brain Function Monitoring.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Karen Stavris · Yale School of Medicine Department of Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2019-09-05
Completion
2019-09-06
FDA Device
Yes

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 NCT03330236 on ClinicalTrials.gov