Trial Outcomes & Findings for EEG - Guided Anesthetic Care and Postoperative Delirium (NCT NCT03330236)
NCT ID: NCT03330236
Last Updated: 2020-11-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1560 participants
Primary outcome timeframe
up to five (5) days after surgery
Results posted on
2020-11-09
Participant Flow
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.
Participant milestones
| Measure |
EEG Guided
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.
|
Usual Care
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 Study
STARTED
|
779
|
781
|
|
Overall Study
Received Surgery
|
779
|
781
|
|
Overall Study
Modified ITT
|
773
|
774
|
|
Overall Study
COMPLETED
|
679
|
697
|
|
Overall Study
NOT COMPLETED
|
100
|
84
|
Reasons for withdrawal
| Measure |
EEG Guided
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.
|
Usual Care
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 Study
Death
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Protocol Violation
|
4
|
3
|
|
Overall Study
SedLine malfunction/blinding
|
19
|
14
|
|
Overall Study
Volatile anesthetics used
|
11
|
8
|
|
Overall Study
Surgery aborted/converted to open
|
60
|
52
|
Baseline Characteristics
EEG - Guided Anesthetic Care and Postoperative Delirium
Baseline characteristics by cohort
| Measure |
EEG Guided
n=773 Participants
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.
|
Usual Care
n=774 Participants
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
n=1547 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
61 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
335 Participants
n=5 Participants
|
315 Participants
n=7 Participants
|
650 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
438 Participants
n=5 Participants
|
459 Participants
n=7 Participants
|
897 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
773 Participants
n=5 Participants
|
774 Participants
n=7 Participants
|
1547 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
773 participants
n=5 Participants
|
774 participants
n=7 Participants
|
1547 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to five (5) days after surgeryPopulation: Modified ITT population
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.
Outcome measures
| Measure |
EEG Guided
n=773 Participants
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.
|
Usual Care
n=774 Participants
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.
|
|---|---|---|
|
Number of Participants With Postoperative Delirium
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 min following the extubationPopulation: Modified ITT population
Incidence (count) of emergence delirium at post-anesthesia care unit (PACU)
Outcome measures
| Measure |
EEG Guided
n=773 Participants
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.
|
Usual Care
n=774 Participants
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.
|
|---|---|---|
|
Emergence Delirium
|
91 Participants
|
102 Participants
|
SECONDARY outcome
Timeframe: within 30 days after surgeryPopulation: Modified ITT population/patients with valid data.
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
Outcome measures
| Measure |
EEG Guided
n=768 Participants
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.
|
Usual Care
n=773 Participants
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.
|
|---|---|---|
|
Non-delirium Complications
|
175 Participants
|
193 Participants
|
SECONDARY outcome
Timeframe: within 30 days after surgeryPopulation: These data were not collected and analyzed.
Speed of GI functional recovery (pass gas)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days after surgeryPopulation: Modified ITT population/patients with complete data
All-cause 30-day mortality
Outcome measures
| Measure |
EEG Guided
n=765 Participants
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.
|
Usual Care
n=767 Participants
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 30-day Mortality
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 30 days after surgeryPopulation: Modified ITT population
Length of hospital stay was counted from the day of surgery (day 0) to the day when the patient was ready for discharge.
Outcome measures
| Measure |
EEG Guided
n=773 Participants
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.
|
Usual Care
n=774 Participants
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.
|
|---|---|---|
|
Length of Hospital Stay
|
6 days
Interval 3.0 to 8.0
|
6 days
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: up to 72 hoursPopulation: Modified ITT population
Count of patients that were admitted to ICU after surgery.
Outcome measures
| Measure |
EEG Guided
n=773 Participants
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.
|
Usual Care
n=774 Participants
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.
|
|---|---|---|
|
ICU Admission
|
17 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: up to 30 days after surgeryPopulation: These data were not collected and analyzed.
the duration of time when the patient residing in ICU
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hours after surgeryPopulation: These data were not collected and analyzed.
Numeric Rating Scale subjective pain where 0 indicates no pain and 10 indicates the worst pain.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hours after surgeryPopulation: These data were not collected and analyzed.
Numeric Rating Scale subjective sleep quality at 8:00 am where 0 indicates best possible sleep and 10 indicates worst possible sleep
Outcome measures
Outcome data not reported
Adverse Events
EEG Guided
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Usual Care
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EEG Guided
n=779 participants at risk
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.
|
Usual Care
n=781 participants at risk
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.
|
|---|---|---|
|
General disorders
Intraoperative awareness
|
0.39%
3/779 • Number of events 3 • Up to 30 days post surgery
|
0.38%
3/781 • Number of events 3 • Up to 30 days post surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place