Trial Outcomes & Findings for Electroencephalography Guidance of Anesthesia (NCT NCT02241655)
NCT ID: NCT02241655
Last Updated: 2019-07-30
Results Overview
Delirium will be assessed at baseline and then once a day postoperative for up to 5 days. Patients were assessed for delirium using the Confusion Assessment Method for verbal patients or the Confusion Assessment Method for the Intensive Care Unit for non verbal or intubated patients, and patients medical records were reviewed for evidence of delirium by doctors and nurses assessments. Patients were considered to have delirium by any modality at anytime postoperative day one through five.
UNKNOWN
NA
1400 participants
5 days
2019-07-30
Participant Flow
1400 participants were consented to the study168 were not randomized to a study treatment arm (2 died, 49 were ineligible after enrollment, 49 surgery was cancelled, 31 research team missed the surgery, 37 withdrew). A total of 1232 patients were randomized to a study arm.
Participant milestones
| Measure |
EEG Guided Protocol
Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.
a pragmatic EEG-guided anesthetic protocol
|
Control Arm
Participants will have the standard anesthetic protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
614
|
618
|
|
Overall Study
COMPLETED
|
614
|
618
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electroencephalography Guidance of Anesthesia
Baseline characteristics by cohort
| Measure |
EEG Guided Protocol
n=614 Participants
Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.
a pragmatic EEG-guided anesthetic protocol
|
Control Arm
n=618 Participants
Participants will have the standard anesthetic protocol.
|
Total
n=1232 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.5 years
n=5 Participants
|
69.4 years
n=7 Participants
|
69.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
282 Participants
n=5 Participants
|
281 Participants
n=7 Participants
|
563 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
332 Participants
n=5 Participants
|
337 Participants
n=7 Participants
|
669 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
555 participants
n=5 Participants
|
558 participants
n=7 Participants
|
1113 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
54 participants
n=5 Participants
|
53 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
614 Participants
n=5 Participants
|
618 Participants
n=7 Participants
|
1232 Participants
n=5 Participants
|
|
BMI
|
29.0 kg/m^2
n=5 Participants
|
29.0 kg/m^2
n=7 Participants
|
29.0 kg/m^2
n=5 Participants
|
|
Attended College
|
198 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
406 Participants
n=5 Participants
|
|
Lifetime tobacco use
|
376 Participants
n=5 Participants
|
349 Participants
n=7 Participants
|
725 Participants
n=5 Participants
|
|
Number of Participants with a Weekly Alcohol Intake
|
289 Participants
n=5 Participants
|
297 Participants
n=7 Participants
|
586 Participants
n=5 Participants
|
|
Current use of anticonvulsants
|
94 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Regular use of opioids
|
154 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Regular use of benzodiazepine
|
86 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Number of participants with American Society of Anesthesiologist Classification greater than 3
|
209 Participants
n=5 Participants
|
221 Participants
n=7 Participants
|
430 Participants
n=5 Participants
|
|
Marginal exercise tolerance (METs) less than 4
|
297 Participants
n=5 Participants
|
295 Participants
n=7 Participants
|
592 Participants
n=5 Participants
|
|
Pulmonary hypertension
|
97 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Aortic stenosis
|
90 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
History or high risk OSA
|
230 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
449 Participants
n=5 Participants
|
|
History of delirium
|
78 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Number of comorbidities
|
5 Number of comorbidities
n=5 Participants
|
5 Number of comorbidities
n=7 Participants
|
5 Number of comorbidities
n=5 Participants
|
|
History of depression
|
85 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Personal Health Questionnaire Depression Scale (PHQ-8)
|
3 units on a scale
n=5 Participants
|
3 units on a scale
n=7 Participants
|
3.0 units on a scale
n=5 Participants
|
|
Short Blessed Test (SBT)
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
2.0 units on a scale
n=5 Participants
|
|
8-item Inerview-Differentiate Aging and Dementia (AD8)
|
0 units on a scale
n=5 Participants
|
0 units on a scale
n=7 Participants
|
0.0 units on a scale
n=5 Participants
|
|
Barthel Activies of Daily Living
|
15 units on a scale
n=5 Participants
|
15 units on a scale
n=7 Participants
|
15 units on a scale
n=5 Participants
|
|
Hand grip strength
|
26.4 kg
STANDARD_DEVIATION 11.0 • n=5 Participants
|
25.7 kg
STANDARD_DEVIATION 10.7 • n=7 Participants
|
26.1 kg
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Timed up and go
|
10.5 seconds
n=5 Participants
|
11.0 seconds
n=7 Participants
|
10.8 seconds
n=5 Participants
|
|
Lawton Instrumental Activities of Daily Living
|
8 units on a scale
n=5 Participants
|
8 units on a scale
n=7 Participants
|
8 units on a scale
n=5 Participants
|
|
Physical Veterans Rand 12 Item Health Survey (VR-12) Score
|
38.1 Physical Score
STANDARD_DEVIATION 11.9 • n=5 Participants
|
38.2 Physical Score
STANDARD_DEVIATION 11.8 • n=7 Participants
|
38.1 Physical Score
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Mental VR-12 score
|
53.6 Mental Score
STANDARD_DEVIATION 10.6 • n=5 Participants
|
53.6 Mental Score
STANDARD_DEVIATION 11.0 • n=7 Participants
|
53.6 Mental Score
STANDARD_DEVIATION 10.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 5 daysPopulation: A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).
Delirium will be assessed at baseline and then once a day postoperative for up to 5 days. Patients were assessed for delirium using the Confusion Assessment Method for verbal patients or the Confusion Assessment Method for the Intensive Care Unit for non verbal or intubated patients, and patients medical records were reviewed for evidence of delirium by doctors and nurses assessments. Patients were considered to have delirium by any modality at anytime postoperative day one through five.
Outcome measures
| Measure |
EEG Guided Protocol
n=604 Participants
Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.
a pragmatic EEG-guided anesthetic protocol
|
Control Arm
n=609 Participants
Participants will have the standard anesthetic protocol.
|
Delirium POD 2-5
Patients who were delirious POD 2-5
|
|---|---|---|---|
|
Number of Participants With Delirium
|
157 Participants
|
140 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year postoperativelyThe hypothesis is that the EEG-guided anesthetic protocol and providing a safety intervention will prevent subsequent injurious falls. Falls will be assessed using the Prevention of Falls Network Europe (ProFaNE) questions. At baseline questions will be asked about preoperative falls, and at 30-days and 1-year postoperatively, questions will be asked about postoperative falls.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one year postoperativelyThe hypothesis is that the EEG-guided anesthetic protocol will improve postoperative quality of life. Patient self-reported Health-related Quality of Life information will be assessed through the Veteran's RAND 12-item Health Survey at baseline and during follow-up (30-day and 1-year).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysPopulation: A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).
Duration will be calculated by the number of positive CAM,CAM-ICU or delirium chart reviews.
Outcome measures
| Measure |
EEG Guided Protocol
n=604 Participants
Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.
a pragmatic EEG-guided anesthetic protocol
|
Control Arm
n=609 Participants
Participants will have the standard anesthetic protocol.
|
Delirium POD 2-5
Patients who were delirious POD 2-5
|
|---|---|---|---|
|
Duration of Delirium
|
1 days
Interval 1.0 to 3.0
|
1 days
Interval 1.0 to 3.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysThe Family Confusion Assessment Method (FAM-CAM) instrument has previously been shown to have good agreement with the CAM and with DSM-IV diagnostic criteria in patients with cognitive impairment and in hospitalized patients.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post dischargeAs measured by the FAM-CAM and patient perceptions
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearDelirium incidence, duration and severity have all been shown to be associated with other (downstream) clinically relevant outcomes, including mortality, length of ICU stay, length of hospital stay, falls, cognitive decline and functional decline.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysGiven that postoperative delirium is common and may relate to uncontrolled pain, this has important implications for the assessment and treatment of postoperative pain. We plan to compare patient reported and behavioral pain assessments in both non-delirious and delirious patients.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayPopulation: A total of 84 patients had analyzable data and included in the analysis. Patients were pooled regardless of intervention (EEG guidance or usual care) since the primary outcome was to assess whether using actigraphy could predict delirium regardless of interventions. Therefore, patients were separated by delirious and non-delirious patients.
Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. Median activity count was calculated from all minutes with nonzero RMS activity within each epoch- higher values indicate more movement.
Outcome measures
| Measure |
EEG Guided Protocol
n=51 Participants
Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.
a pragmatic EEG-guided anesthetic protocol
|
Control Arm
n=24 Participants
Participants will have the standard anesthetic protocol.
|
Delirium POD 2-5
n=13 Participants
Patients who were delirious POD 2-5
|
|---|---|---|---|
|
Postoperative Actigraphy
|
134 minutes RMSactivity>0
Interval 59.0 to 195.0
|
101 minutes RMSactivity>0
Interval 50.0 to 141.0
|
93 minutes RMSactivity>0
Interval 36.0 to 236.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysPopulation: Patients who were in the ICU, had a nursing CAM-ICU assessment and researcher's delirium assessment were included in this analysis. Agreement between the instruments was calculated using Kappa agreement.
Routine clinical (i.e. conducted by ICU nursing staff) delirium assessments in the intensive care units (conducted with the CAM-ICU) will be collected when these are available. Comparison will be made on the outcome of the assessment (positive for delirium or negative by delirium) between these routine clinical assessments and the assessments made by the research team. Since the purpose of this is to determine whether clinical staff are picking up episodes of delirium compared to researcher's assessment in all patients regardless of treatment group, data from both treatment arms were combined for the analysis.
Outcome measures
| Measure |
EEG Guided Protocol
n=562 Participants
Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.
a pragmatic EEG-guided anesthetic protocol
|
Control Arm
Participants will have the standard anesthetic protocol.
|
Delirium POD 2-5
Patients who were delirious POD 2-5
|
|---|---|---|---|
|
Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments
|
0.37 Cohen's kappa coefficient
Interval 0.29 to 0.44
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearThere is an ongoing randomized, clinical trial investigating the effects of depth of anesthesia on a range of outcomes98, including death, myocardial infarction, cardiac arrest, pulmonary embolus, stroke, surgical site infection, ICU length of stay, hospital length of stay, intraoperative awareness, persistent pain and cancer recurrence. Many of these outcomes are tracked with the SATISFY-SOS study, and will therefore be reported for patients enrolled in the ENGAGES study.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysPopulation: Covariated included were pre-selected and considered likely to be associated with postoperative delirium.
It is important to improve our understanding of factors that are associated with an increased incidence of postoperative delirium or perhaps may even mediate an elevated risk for postoperative delirium. The arm/group was included in the model to determine if it was associated with postoperative delirium therefore data is not presented by arm/group.
Outcome measures
| Measure |
EEG Guided Protocol
n=1051 Participants
Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.
a pragmatic EEG-guided anesthetic protocol
|
Control Arm
Participants will have the standard anesthetic protocol.
|
Delirium POD 2-5
Patients who were delirious POD 2-5
|
|---|---|---|---|
|
Delirium Prediction Models
Preoperative opioids
|
1.27 odds ratio
Interval 0.88 to 1.82
|
—
|
—
|
|
Delirium Prediction Models
Preoperative sodium level
|
0.98 odds ratio
Interval 0.94 to 1.03
|
—
|
—
|
|
Delirium Prediction Models
Preoperative creatinine level
|
1.06 odds ratio
Interval 0.91 to 1.22
|
—
|
—
|
|
Delirium Prediction Models
Preoperative hemoglobin level
|
0.99 odds ratio
Interval 0.91 to 1.08
|
—
|
—
|
|
Delirium Prediction Models
Cardiac surgery
|
0.92 odds ratio
Interval 0.58 to 1.44
|
—
|
—
|
|
Delirium Prediction Models
Hearing aid use
|
0.82 odds ratio
Interval 0.52 to 1.3
|
—
|
—
|
|
Delirium Prediction Models
No. Comorbidities
|
1.08 odds ratio
Interval 1.01 to 1.16
|
—
|
—
|
|
Delirium Prediction Models
ASA greater than 3
|
1.98 odds ratio
Interval 1.27 to 3.09
|
—
|
—
|
|
Delirium Prediction Models
Marginal exercise tolerance less than 4 METS
|
1.21 odds ratio
Interval 0.86 to 1.7
|
—
|
—
|
|
Delirium Prediction Models
Falls in previous 6 months
|
1.25 odds ratio
Interval 0.88 to 1.76
|
—
|
—
|
|
Delirium Prediction Models
Preoperative benzodiazepines
|
1.28 odds ratio
Interval 0.85 to 1.94
|
—
|
—
|
|
Delirium Prediction Models
Guided Group
|
1.12 odds ratio
Interval 0.3 to 1.64
|
—
|
—
|
|
Delirium Prediction Models
Age
|
1.04 odds ratio
Interval 1.02 to 1.06
|
—
|
—
|
|
Delirium Prediction Models
Male
|
0.99 odds ratio
Interval 0.71 to 1.38
|
—
|
—
|
|
Delirium Prediction Models
White
|
0.46 odds ratio
Interval 0.28 to 0.74
|
—
|
—
|
|
Delirium Prediction Models
Living alone
|
0.91 odds ratio
Interval 0.63 to 1.32
|
—
|
—
|
|
Delirium Prediction Models
History of delirium
|
1.83 odds ratio
Interval 1.21 to 2.76
|
—
|
—
|
|
Delirium Prediction Models
Preoperative PHQ8
|
1.03 odds ratio
Interval 0.99 to 1.07
|
—
|
—
|
|
Delirium Prediction Models
Preoperative Lawton
|
0.95 odds ratio
Interval 0.83 to 1.09
|
—
|
—
|
|
Delirium Prediction Models
Preoperative Barthel
|
0.95 odds ratio
Interval 0.81 to 1.12
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsThe ENGAGES study is being conducted in collaboration with complementary trials at the University of California, San Francisco (UCSF) (NCT01983384), the University of Michigan in Ann Arbor and the University of Manitoba in Winnipeg. Some of the outcomes will be analyzed considering data from some or all of these studies, as appropriate. In terms of the practicality of disseminating the EEG-guided protocol in North America and beyond, it will be important to demonstrate the feasibility and impact of the protocol in multiple sites.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysPopulation: A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).
The severity of delirium will be scored using the CAM-Severity (CAM-S) metric, which has specifically been shown to be strongly associated with clinically relevant outcomes. Severe delirium was defined as patients with a CAM-S score of 10 or greater (range 0-19).
Outcome measures
| Measure |
EEG Guided Protocol
n=604 Participants
Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.
a pragmatic EEG-guided anesthetic protocol
|
Control Arm
n=609 Participants
Participants will have the standard anesthetic protocol.
|
Delirium POD 2-5
Patients who were delirious POD 2-5
|
|---|---|---|---|
|
Number of Participants With Severe Delirium
|
59 Participants
|
51 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 daysEEG abnormalities have previously been associated with postoperative delirium
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayPopulation: A total of 84 patients had analyzable data and included in the analysis. Patients were pooled regardless of intervention (EEG guidance or usual care) since the primary outcome was to assess whether using actigraphy could predict delirium regardless of interventions. Therefore, patients were separated by delirious and non-delirious patients.
Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. We quantified inactivity using the number of immobile minutes, defined as the total number of minutes with an RMSactivity count of zero- higher number indicates patient had more time being immobile.
Outcome measures
| Measure |
EEG Guided Protocol
n=51 Participants
Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.
a pragmatic EEG-guided anesthetic protocol
|
Control Arm
n=24 Participants
Participants will have the standard anesthetic protocol.
|
Delirium POD 2-5
n=13 Participants
Patients who were delirious POD 2-5
|
|---|---|---|---|
|
Postoperative Actigraphy- Immobile Minutes
|
548 minutes RMSactivity=0
Interval 472.0 to 625.0
|
584 minutes RMSactivity=0
Interval 430.0 to 620.0
|
604 minutes RMSactivity=0
Interval 440.0 to 683.0
|
Adverse Events
EEG Guided Protocol
Control Arm
Serious adverse events
| Measure |
EEG Guided Protocol
n=614 participants at risk
Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.
a pragmatic EEG-guided anesthetic protocol
|
Control Arm
n=618 participants at risk
Participants will have the standard anesthetic protocol.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding/anemia requiring unexpected transfusion
|
0.81%
5/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.8%
11/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Blood and lymphatic system disorders
Embolus
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.32%
2/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Blood and lymphatic system disorders
Thrombosis without embolus
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.81%
5/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Blood and lymphatic system disorders
Other hematologic event
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.00%
0/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Cardiac Arrest
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.9%
12/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Cardiac tamponade
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.00%
0/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Congestive heart failure
|
0.65%
4/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.32%
2/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Myocardial infarction
|
0.49%
3/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.81%
5/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Unexpected atrial fibrillation
|
0.33%
2/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.32%
2/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Unexpected cardiogenic shock
|
0.33%
2/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.97%
6/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Unexpected heart block
|
0.49%
3/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.49%
3/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Other unexpected abnormal heart rhythms
|
0.00%
0/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.81%
5/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Endocrine disorders
Unexpected hypo or hyperkelemia
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.00%
0/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Endocrine disorders
Unexpected hypo or hypernatremia
|
0.00%
0/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Endocrine disorders
Other endocrine or metabolic event
|
0.49%
3/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.81%
5/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Gastrointestinal disorders
Anastomotic leak
|
0.00%
0/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.49%
3/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Gastrointestinal disorders
Nausea and/or vomiting
|
1.3%
8/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.49%
3/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Gastrointestinal disorders
GI bleed
|
0.81%
5/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Gastrointestinal disorders
Ileus/bowel obstruction
|
2.0%
12/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.3%
8/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Gastrointestinal disorders
Other GI event
|
2.3%
14/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
2.9%
18/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Immune system disorders
Anaphylaxis
|
0.33%
2/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Immune system disorders
Infectious colitis
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.65%
4/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Immune system disorders
Sepsis
|
1.5%
9/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.8%
11/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Immune system disorders
UTI
|
0.33%
2/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Immune system disorders
Wound infection
|
1.8%
11/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
2.1%
13/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Immune system disorders
Other immune or infectious event
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.49%
3/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.00%
0/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Nervous system disorders
Stroke
|
1.6%
10/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.65%
4/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Nervous system disorders
Pain
|
0.33%
2/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.00%
0/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Nervous system disorders
Other neurological event
|
0.49%
3/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.65%
4/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
0.49%
3/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.49%
3/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.6%
10/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.49%
3/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failures
|
3.4%
21/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
4.4%
27/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory event
|
0.98%
6/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.32%
2/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Renal and urinary disorders
Acute kidney injury
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.97%
6/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Renal and urinary disorders
Renal failure requiring dialysis
|
0.98%
6/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.1%
7/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Renal and urinary disorders
Urinary retention
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.00%
0/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Renal and urinary disorders
Other renal event
|
0.49%
3/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.49%
3/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Vascular disorders
Non-cardiogenic shock
|
0.65%
4/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Vascular disorders
Unexpected hypotension
|
0.65%
4/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Vascular disorders
Other vascular event
|
1.1%
7/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.5%
9/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Surgical and medical procedures
Other body system event
|
2.0%
12/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
2.3%
14/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
Other adverse events
| Measure |
EEG Guided Protocol
n=614 participants at risk
Participants will have a pragmatic EEG-guided anesthetic protocol during their surgery. Practitioners will modify administration of anesthesia in an attempt to limit the occurrence of EEG burst suppression or persistent suppression.
a pragmatic EEG-guided anesthetic protocol
|
Control Arm
n=618 participants at risk
Participants will have the standard anesthetic protocol.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding/anemia requiring unexpected transfusion
|
19.7%
121/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
20.4%
126/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Blood and lymphatic system disorders
Embolus
|
0.00%
0/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.9%
24/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
3.7%
23/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Blood and lymphatic system disorders
Thrombosis without embolus
|
2.4%
15/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.9%
12/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Blood and lymphatic system disorders
Other hematologic event
|
0.33%
2/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.81%
5/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Unexpected atrial fibrillation
|
11.9%
73/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
15.7%
97/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Unexpected cardiogenic shock
|
0.98%
6/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.81%
5/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Unexpected heart block
|
2.8%
17/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
2.4%
15/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Other unexpected abnormal heart rhythms
|
1.5%
9/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
2.4%
15/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Other cardiac event
|
1.6%
10/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.1%
7/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Endocrine disorders
unexpected hypo or hyperglycemia
|
0.00%
0/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.81%
5/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Endocrine disorders
Unexpected hypo or hyperkalemia
|
1.5%
9/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.49%
3/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Endocrine disorders
Unexpected hypo or hypernatremia
|
2.1%
13/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.97%
6/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Endocrine disorders
Other endocrine event
|
0.81%
5/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.81%
5/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Gastrointestinal disorders
Nausea and/or vomiting
|
1.5%
9/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.6%
10/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Gastrointestinal disorders
GI bleed
|
0.33%
2/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.49%
3/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Gastrointestinal disorders
Ileus/bowel obstruction
|
3.6%
22/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
3.6%
22/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Gastrointestinal disorders
Other GI event
|
2.0%
12/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.8%
11/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Immune system disorders
Infectious colitis
|
0.98%
6/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.49%
3/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Immune system disorders
Non-anaphylactic allergic reaction
|
0.49%
3/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Immune system disorders
Sepsis
|
0.00%
0/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.49%
3/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Immune system disorders
UTI
|
3.3%
20/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
3.1%
19/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Immune system disorders
Wound infection
|
2.3%
14/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.6%
10/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Immune system disorders
Other immune event
|
3.1%
19/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
2.3%
14/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Nervous system disorders
Stroke
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.00%
0/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Nervous system disorders
Pain
|
0.65%
4/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Nervous system disorders
Other neurological event
|
1.1%
7/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.3%
8/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.49%
3/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.32%
2/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
0.33%
2/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.00%
0/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
0.65%
4/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.00%
0/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.16%
1/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.8%
11/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.98%
6/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.6%
10/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.81%
5/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.32%
2/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failures
|
1.5%
9/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.6%
10/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory event
|
3.9%
24/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
2.8%
17/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Renal and urinary disorders
Acute kidney injury
|
6.5%
40/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
6.5%
40/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Renal and urinary disorders
Renal failure requiring dialysis
|
0.00%
0/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Renal and urinary disorders
Urinary retention
|
5.9%
36/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
4.5%
28/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Renal and urinary disorders
Other renal event
|
3.3%
20/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
3.2%
20/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Cardiac disorders
Non-cardiogenic shock
|
0.65%
4/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.49%
3/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Vascular disorders
Unexpected hypertension
|
0.33%
2/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
0.16%
1/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Vascular disorders
Unexpected hypotension
|
2.4%
15/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
3.1%
19/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Vascular disorders
Other vascular event
|
1.3%
8/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
1.8%
11/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
|
Surgical and medical procedures
Other body system event
|
2.1%
13/614 • Adverse events were collected during surgery up to 30 days postoperatively
|
2.1%
13/618 • Adverse events were collected during surgery up to 30 days postoperatively
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place