Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

EEG - Guided Anesthetic Care and Postoperative Delirium (EMODIPOD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330236
Recruitment Status : Completed
First Posted : November 6, 2017
Results First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Delirium
Emergence Delirium
Anesthesia, General
Electroencephalography
Laparoscopy
Surgical Procedures, Operative
Intervention Device: Anesthetic "depth" management
Enrollment 1560
Recruitment Details Among the 70,783 patients scheduled to undergo an elective surgical procedure in the main operating rooms at Xiangya Hospital from October 2017 to August 2019, a total of 1,560 participated in this study.
Pre-assignment Details  
Arm/Group Title EEG Guided Usual Care
Hide Arm/Group Description

All patients in the EEG Guided 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.

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.

All patients in the usual care arm (control) 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.
Period Title: Overall Study
Started 779 781
Received Surgery 779 781
Modified ITT [1] 773 774
Completed 679 697
Not Completed 100 84
Reason Not Completed
Death             2             1
Withdrawal by Subject             2             4
Lost to Follow-up             0             2
Physician Decision             2             0
Protocol Violation             4             3
SedLine malfunction/blinding             19             14
Volatile anesthetics used             11             8
Surgery aborted/converted to open             60             52
[1]
Participants analyzed as the Modified ITT analysis population.
Arm/Group Title EEG Guided Usual Care Total
Hide Arm/Group Description

All patients in the EEG Guided 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.

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.

All patients in the usual care arm (control) 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. Total of all reporting groups
Overall Number of Baseline Participants 773 774 1547
Hide Baseline Analysis Population Description
Modified ITT population
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 773 participants 774 participants 1547 participants
62
(55 to 67)
61
(55 to 67)
61
(55 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 773 participants 774 participants 1547 participants
Female
335
  43.3%
315
  40.7%
650
  42.0%
Male
438
  56.7%
459
  59.3%
897
  58.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 773 participants 774 participants 1547 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
773
 100.0%
774
 100.0%
1547
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 773 participants 774 participants 1547 participants
773 774 1547
1.Primary Outcome
Title Number of Participants With Postoperative Delirium
Hide Description 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.
Time Frame up to five (5) days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT population
Arm/Group Title EEG Guided Usual Care
Hide Arm/Group Description:

All patients in the EEG Guided 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.

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.

All patients in the usual care arm (control) 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.
Overall Number of Participants Analyzed 773 774
Measure Type: Count of Participants
Unit of Measure: Participants
8
   1.0%
9
   1.2%
2.Secondary Outcome
Title Emergence Delirium
Hide Description Incidence (count) of emergence delirium at post-anesthesia care unit (PACU)
Time Frame 30 min following the extubation
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT population
Arm/Group Title EEG Guided Usual Care
Hide Arm/Group Description:

All patients in the EEG Guided 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.

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.

All patients in the usual care arm (control) 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.
Overall Number of Participants Analyzed 773 774
Measure Type: Count of Participants
Unit of Measure: Participants
91
  11.8%
102
  13.2%
3.Secondary Outcome
Title Non-delirium Complications
Hide Description

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

Time Frame within 30 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT population/patients with valid data.
Arm/Group Title EEG Guided Usual Care
Hide Arm/Group Description:

All patients in the EEG Guided 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.

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.

All patients in the usual care arm (control) 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.
Overall Number of Participants Analyzed 768 773
Measure Type: Count of Participants
Unit of Measure: Participants
175
  22.8%
193
  25.0%
4.Secondary Outcome
Title GI Functional Recovery
Hide Description Speed of GI functional recovery (pass gas)
Time Frame within 30 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
These data were not collected and analyzed.
Arm/Group Title EEG Guided Usual Care
Hide Arm/Group Description:

All patients in the EEG Guided 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.

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.

All patients in the usual care arm (control) 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title All-cause 30-day Mortality
Hide Description All-cause 30-day mortality
Time Frame 30 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT population/patients with complete data
Arm/Group Title EEG Guided Usual Care
Hide Arm/Group Description:

All patients in the EEG Guided 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.

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.

All patients in the usual care arm (control) 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.
Overall Number of Participants Analyzed 765 767
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.3%
1
   0.1%
6.Secondary Outcome
Title Length of Hospital Stay
Hide Description Length of hospital stay was counted from the day of surgery (day 0) to the day when the patient was ready for discharge.
Time Frame up to 30 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT population
Arm/Group Title EEG Guided Usual Care
Hide Arm/Group Description:

All patients in the EEG Guided 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.

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.

All patients in the usual care arm (control) 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.
Overall Number of Participants Analyzed 773 774
Median (Inter-Quartile Range)
Unit of Measure: days
6
(3 to 8)
6
(3 to 8)
7.Secondary Outcome
Title ICU Admission
Hide Description Count of patients that were admitted to ICU after surgery.
Time Frame up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT population
Arm/Group Title EEG Guided Usual Care
Hide Arm/Group Description:

All patients in the EEG Guided 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.

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.

All patients in the usual care arm (control) 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.
Overall Number of Participants Analyzed 773 774
Measure Type: Count of Participants
Unit of Measure: Participants
17
   2.2%
15
   1.9%
8.Secondary Outcome
Title Length of ICU Stay
Hide Description the duration of time when the patient residing in ICU
Time Frame up to 30 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
These data were not collected and analyzed.
Arm/Group Title EEG Guided Usual Care
Hide Arm/Group Description:

All patients in the EEG Guided 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.

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.

All patients in the usual care arm (control) 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Other Pre-specified Outcome
Title NRS Pain Score
Hide Description Numeric Rating Scale subjective pain where 0 indicates no pain and 10 indicates the worst pain.
Time Frame 24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
These data were not collected and analyzed.
Arm/Group Title EEG Guided Usual Care
Hide Arm/Group Description:

All patients in the EEG Guided 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.

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.

All patients in the usual care arm (control) 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Other Pre-specified Outcome
Title NRS Sleep Score
Hide Description Numeric Rating Scale subjective sleep quality at 8:00 am where 0 indicates best possible sleep and 10 indicates worst possible sleep
Time Frame 24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
These data were not collected and analyzed.
Arm/Group Title EEG Guided Usual Care
Hide Arm/Group Description:

All patients in the EEG Guided 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.

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.

All patients in the usual care arm (control) 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 30 days post surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EEG Guided Usual Care
Hide Arm/Group Description

All patients in the EEG Guided 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.

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.

All patients in the usual care arm (control) 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.
All-Cause Mortality
EEG Guided Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   2/779 (0.26%)      1/781 (0.13%)    
Hide Serious Adverse Events
EEG Guided Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/779 (0.00%)      0/781 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EEG Guided Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/779 (0.39%)      3/781 (0.38%)    
General disorders     
Intraoperative awareness   3/779 (0.39%)  3 3/781 (0.38%)  3
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lingzhong Meng, MD
Organization: Yale University
Phone: (203) 785-2198
EMail: lingzhong.meng@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03330236    
Other Study ID Numbers: 201612631
First Submitted: October 19, 2017
First Posted: November 6, 2017
Results First Submitted: October 9, 2020
Results First Posted: November 9, 2020
Last Update Posted: November 9, 2020