N/A
N=1,560
EEG - Guided Anesthetic Care and Postoperative Delirium
Delirium · Emergence Delirium · Anesthesia, General · Electroencephalography · Laparoscopy
Bottom Line
View on ClinicalTrials.gov: NCT03330236 ↗Enrolled (actual)
1,560
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Postoperative Delirium — 8; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anesthetic "depth" management (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postoperative Delirium |
8; 9 | — |
| SECONDARY Emergence Delirium |
91; 102 | — |
| SECONDARY Non-delirium Complications |
175; 193 | — |
| SECONDARY GI Functional Recovery |
— | — |
| SECONDARY All-cause 30-day Mortality |
2; 1 | — |
| SECONDARY Length of Hospital Stay |
6; 6 | — |
| SECONDARY ICU Admission |
17; 15 | — |
| SECONDARY Length of ICU Stay |
— | — |
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
Eligibility Criteria
Inclusion Criteria
- Age ≥ 50 years;
- ASA Physical Score I-III
- Scheduled to undergo elective laparoscopic surgeries under general anesthesia with endotracheal intubation;
- Extubation expected after surgery;
- Scheduled to stay in hospital for > 3 days after surgery.
Exclusion Criteria
- Refuse to participate;
- Emergent surgery;
- Trauma patients;
- Preoperative cognitive impairment characterized by Mini-Mental State Examination (MMSE) of 23 or less;
- Preoperative history of stroke, schizophrenia, major depression, Parkinson's disease, epilepsy, or dementia;
- Inability to communicate in the preoperative period due to illiteracy, language difficulties, or significant hearing or visual impairment;
- Inability to complete MMSE and delirium survey;
- Severe cardiac disease including low-output cardiac failure defined as a preoperative left ventricular ejection fraction < 30%, or arrhythmia with pacemaker or AICD placement;
- Severe hepatic dysfunction being evaluated for liver transplantation or with a Child- Pugh Class C classification;
- Severe renal dysfunction requiring renal replacement therapy before surgery;
- Those with preoperative ASA classification of 4 or who are unlikely to survive for more than 3 days after surgery.
Data sourced from ClinicalTrials.gov (NCT03330236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.