EEG - Guided Anesthetic Care and Postoperative Delirium (EMODIPOD)

Yale University

Status: Completed

Conditions: Surgical Procedures, Operative; Electroencephalography; Delirium; Laparoscopy; Emergence Delirium; Anesthesia, General

Treatments: Device: Anesthetic "depth" management

Study type: Interventional

Funder types: Other

Identifiers

NCT03330236

201612631

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,560 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 50 years;
2. ASA Physical Score I-III
3. Scheduled to undergo elective laparoscopic surgeries under general anesthesia with endotracheal intubation;
4. Extubation expected after surgery;
5. Scheduled to stay in hospital for > 3 days after surgery.

Exclusion criteria

1. Refuse to participate;
2. Emergent surgery;
3. Trauma patients;
4. Preoperative cognitive impairment characterized by Mini-Mental State Examination (MMSE) of 23 or less;
5. Preoperative history of stroke, schizophrenia, major depression, Parkinson's disease, epilepsy, or dementia;
6. Inability to communicate in the preoperative period due to illiteracy, language difficulties, or significant hearing or visual impairment;
7. Inability to complete MMSE and delirium survey;
8. Severe cardiac disease including low-output cardiac failure defined as a preoperative left ventricular ejection fraction < 30%, or arrhythmia with pacemaker or AICD placement;
9. Severe hepatic dysfunction being evaluated for liver transplantation or with a Child- Pugh Class C classification;
10. Severe renal dysfunction requiring renal replacement therapy before surgery;
11. Those with preoperative ASA classification of 4 or who are unlikely to survive for more than 3 days after surgery.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,560 participants in 2 patient groups

Study arm

Experimental group

Description:

All patients in the study arm will receive the anesthetic care guided by the SedLine EEG Brain Function Monitor in addition to the conventional monitors. In addition to the conventional/standard interventions of anesthetic care, an additional intervention related to this trial is the anesthetic "depth" management via the titration of the propofol and remifentanil infusion rates to maintain SEF and PSI in the targeted ranges based on the SedLine EEG monitoring.

Treatment:

Device: Anesthetic "depth" management

Control arm

No Intervention group

Description:

All patients in the control arm will receive the anesthetic care guided by the conventional monitors only. Patients in the control arm will be monitored using the SedLine EEG Brain Function Monitor; however, the screen of this monitor will be covered by an opaque cloth and blinded to the anesthesia team.