Trials / Completed
CompletedNCT03330236
EEG - Guided Anesthetic Care and Postoperative Delirium
Effect of Spectral Edge Frequency and Patient State Index (Electroencephalography) - Guided Anesthetic Care on Delirium After Laparoscopic Surgery: the EMODIPOD Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,560 (actual)
- Sponsor
- Yale University · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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
Detailed description
To investigate the impact of the anesthetic care guided by EEG monitor (SedLine) on (1) the incidence of delirium in post-anesthesia care unit (PACU) and within the first five days after laparoscopic surgery and (2) the incidence of in-hospital complications and 30-day mortality in adult patients after laparoscopic surgery.
Conditions
- Delirium
- Emergence Delirium
- Anesthesia, General
- Electroencephalography
- Laparoscopy
- Surgical Procedures, Operative
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-10-13
- Primary completion
- 2019-09-05
- Completion
- 2019-09-06
- First posted
- 2017-11-06
- Last updated
- 2020-11-09
- Results posted
- 2020-11-09
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03330236. Inclusion in this directory is not an endorsement.