EEG - Guided Anesthetic Care and Postoperative Delirium

NCT ID: NCT03330236

Last Updated: 2020-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-13
• Study Completion Date: 2019-09-06

Brief 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

Keywords

Electroencephalography; Spectral edge frequency; Patient state index; Anesthesia; Laparoscopic surgery; Postoperative delirium; Emergence delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Study arm

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.

Group Type: EXPERIMENTAL

Anesthetic "depth" management

Intervention Type: DEVICE

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.

Control arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Stavris

Role: STUDY_DIRECTOR

Yale School of Medicine Department of Anesthesiology

Locations

Xiangya Hospital

Changsha, Hunan, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201612631

Identifier Type: -

Identifier Source: org_study_id