Clinical trial NCT03330236: EEG - Guided Anesthetic Care and Postoperative Delirium
Official title: Effect of Spectral Edge Frequency and Patient State Index (Electroencephalography) - Guided Anesthetic Care on Delirium After Laparoscopic Surgery: the EMODIPOD Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 1560
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a prospective, pragmatic, patient and outcome assessor blinded, randomized 1:1 and controlled parallel trial.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of Participants With Postoperative Delirium
timeFrame: up to five (5) days after surgery
Secondary outcomes:
measure: Emergence Delirium
timeFrame: 30 min following the extubation
measure: Non-delirium Complications
timeFrame: within 30 days after surgery
measure: GI Functional Recovery
timeFrame: within 30 days after surgery
measure: All-cause 30-day Mortality
timeFrame: 30 days after surgery
measure: Length of Hospital Stay
timeFrame: up to 30 days after surgery
measure: ICU Admission
timeFrame: up to 72 hours
measure: Length of ICU Stay
timeFrame: up to 30 days after surgery
Other outcomes:
measure: NRS Pain Score
timeFrame: 24 hours after surgery
measure: NRS Sleep Score
timeFrame: 24 hours after surgery
Locations:
city: Changsha
country: China
facility: Xiangya Hospital
state: Hunan
Study officials:
affiliation: Yale School of Medicine Department of Anesthesiology
name: Karen Stavris
role: STUDY_DIRECTOR
References: