EEG - Guided Anesthetic Care and Postoperative Delirium (EMODIPOD)

Effect of Spectral Edge Frequency and Patient State Index (Electroencephalography) - Guided Anesthetic Care on Delirium After Laparoscopic Surgery: the EMODIPOD Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Delirium; Anesthesia, General; Emergence Delirium; Laparoscopy; Surgical Procedures, Operative; Electroencephalography
• Intervention / Treatment: Device: Anesthetic "depth" management

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.

• Study Type: Interventional
• Enrollment (Actual): 1560
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410205
      • Xiangya Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Postoperative Delirium	The Number of Participants with Postoperative Delirium is operationally defined as the count of patients with postoperative delirium. Postoperative delirium is an acute brain dysfunction characterized by inattention, disorganized thinking, and a fluctuating course.	up to five (5) days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergence Delirium	Incidence (count) of emergence delirium at post-anesthesia care unit (PACU)	30 min following the extubation
Non-delirium Complications	Complications after surgery such as acute kidney injury, cardiac events, cerebrovascular events, renal injury, GI complications, infections (etc) were assessed using the Clavien-Dindo classification. Reported are the count of those with a composite complication Clavien-Dindo Grade ≥II. The classifications are as follows: Grade I = Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II = Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusionsand total parenteral nutritionare also included. Grade III = Requiring surgical, endoscopic or radiological intervention; IIIa = Intervention not under general anesthesia; IIIb = Intervention under general anesthesia. Grade IV = Life-threatening complication (including CNS complications)* requiring IC/ICU-management; IVa = single organ dysfunction (including dialysis); IVb	within 30 days after surgery
GI Functional Recovery	Speed of GI functional recovery (pass gas)	within 30 days after surgery
All-cause 30-day Mortality	All-cause 30-day mortality	30 days after surgery
Length of Hospital Stay	Length of hospital stay was counted from the day of surgery (day 0) to the day when the patient was ready for discharge.	up to 30 days after surgery
ICU Admission	Count of patients that were admitted to ICU after surgery.	up to 72 hours
Length of ICU Stay	the duration of time when the patient residing in ICU	up to 30 days after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS Pain Score	Numeric Rating Scale subjective pain where 0 indicates no pain and 10 indicates the worst pain.	24 hours after surgery
NRS Sleep Score	Numeric Rating Scale subjective sleep quality at 8:00 am where 0 indicates best possible sleep and 10 indicates worst possible sleep	24 hours after surgery

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Study Director: Karen Stavris, Yale School of Medicine Department of Anesthesiology

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 13, 2017
• Primary Completion (ACTUAL): September 5, 2019
• Study Completion (ACTUAL): September 6, 2019

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (ACTUAL): November 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Anesthesia; Emergence delirium; Electroencephalography; Postoperative delirium; Patient state index; Spectral edge frequency
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 201612631

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes