Trial Outcomes & Findings for Brain Function Monitoring During Surgery (NCT NCT06619730)
NCT ID: NCT06619730
Last Updated: 2026-08-12
Results Overview
The primary endpoint is the speed of recovery time, measured from the end time of the surgery, to the time of meeting the criteria for pediatric acute care unit (PACU) discharge. These criteria are lack of nausea/vomiting, grogginess and the level of pain; with 0 being no pain and 10 being severe pain.
COMPLETED
NA
100 participants
Up to 3 hours
2026-08-12
Participant Flow
Participant milestones
| Measure |
Control Arm
Conventional method: Anesthesia will not be guided by the Sedline brain function monitor during the procedure.
|
Sedline Monitor Arm
Anesthesia care guided by Sedline brain function monitor during the procedure. Sedline Brain Function Monitor: The anesthesia provider will use the Sedline Brain Function Monitor information to affect their anesthetic dosing.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Function Monitoring During Surgery
Baseline characteristics by cohort
| Measure |
Control Arm
n=50 Participants
Conventional method: Anesthesia will not be guided by the Sedline brain function monitor during the procedure.
|
Sedline Monitor Arm
n=50 Participants
Anesthesia care guided by Sedline brain function monitor during the procedure.
Sedline Brain Function Monitor: The anesthesia provider will use the Sedline Brain Function Monitor information to affect their anesthetic dosing.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 6.9 • n=1 Participants
|
34 years
STANDARD_DEVIATION 7.3 • n=1 Participants
|
33.5 years
STANDARD_DEVIATION 7.09 • n=1 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=1 Participants
|
23 Participants
n=1 Participants
|
52 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=1 Participants
|
27 Participants
n=1 Participants
|
48 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
19 Participants
n=1 Participants
|
18 Participants
n=1 Participants
|
37 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
23 Participants
n=1 Participants
|
22 Participants
n=1 Participants
|
45 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · Asian or pacific islander
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · Native American
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=1 Participants
|
4 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
5 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
10 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Up to 3 hoursThe primary endpoint is the speed of recovery time, measured from the end time of the surgery, to the time of meeting the criteria for pediatric acute care unit (PACU) discharge. These criteria are lack of nausea/vomiting, grogginess and the level of pain; with 0 being no pain and 10 being severe pain.
Outcome measures
| Measure |
Control Arm
n=50 Participants
Conventional method: Anesthesia will not be guided by the Sedline brain function monitor during the procedure.
|
Sedline Monitor Arm
n=50 Participants
Anesthesia care guided by Sedline brain function monitor during the procedure. Sedline Brain Function Monitor: The anesthesia provider will use the Sedline Brain Function Monitor information to affect their anesthetic dosing.
|
Control Arm - Male Participants
Male participants randomized to Control-arm.
|
Control Arm - Female Participants
Female participants randomized to Control-arm
|
|---|---|---|---|---|
|
Speed of Recovery Time
|
84 minutes
Interval 64.0 to 100.0
|
85 minutes
Interval 68.0 to 106.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 day post surgeryPatient pain level rated postoperatively in recovery and satisfaction with anesthesia experience rated, using validated diagnostics: Numeric Pain Rating Scale (NPRS) Measures patient-reported pain intensity. Score range: 0 to 10 (0 = no pain, 10 = worst imaginable pain) Directionality: Higher scores indicate worse pain. 5-Point Likert Satisfaction Scale Measures overall satisfaction with the anesthetic experience. Score range: 1 to 5 (1 = very dissatisfied, 5 = very satisfied) Directionality: Higher scores indicate better satisfaction.
Outcome measures
| Measure |
Control Arm
n=50 Participants
Conventional method: Anesthesia will not be guided by the Sedline brain function monitor during the procedure.
|
Sedline Monitor Arm
n=50 Participants
Anesthesia care guided by Sedline brain function monitor during the procedure. Sedline Brain Function Monitor: The anesthesia provider will use the Sedline Brain Function Monitor information to affect their anesthetic dosing.
|
Control Arm - Male Participants
Male participants randomized to Control-arm.
|
Control Arm - Female Participants
Female participants randomized to Control-arm
|
|---|---|---|---|---|
|
Patient Rated - PostOperative Pain and Anesthesia Experience
Pain score (0-10)
|
5 score on a scale
Interval 4.0 to 6.0
|
4 score on a scale
Interval 2.0 to 6.0
|
—
|
—
|
|
Patient Rated - PostOperative Pain and Anesthesia Experience
Satisfaction scores (1- 5)
|
5 score on a scale
Interval 4.0 to 5.0
|
5 score on a scale
Interval 5.0 to 5.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 days post surgeryPopulation: Calculated PACU discharge rates (minutes) are gender-stratified for both study arms. Brain Monitoring Arm - Male Control Arm - Male Brain Monitoring Arm - Female Control Arm - Female
Evaluate the PostOperative Care Unit (PACU) discharge length of stay rates (minutes) between randomized study-arms are gender-stratified. Calculated PACU discharge rates will be gender-stratified between study arms. Determining factors for discharge readiness included, electroencephalogram (EEG) interpretation, post-anesthesia recovery and return to baseline, and symptom severity (i.e., nausea, agitation, etc.) Brain Monitoring Arm - Male Control Arm - Male Brain Monitoring Arm - Female Control Arm - Female
Outcome measures
| Measure |
Control Arm
n=21 Participants
Conventional method: Anesthesia will not be guided by the Sedline brain function monitor during the procedure.
|
Sedline Monitor Arm
n=29 Participants
Anesthesia care guided by Sedline brain function monitor during the procedure. Sedline Brain Function Monitor: The anesthesia provider will use the Sedline Brain Function Monitor information to affect their anesthetic dosing.
|
Control Arm - Male Participants
n=27 Participants
Male participants randomized to Control-arm.
|
Control Arm - Female Participants
n=23 Participants
Female participants randomized to Control-arm
|
|---|---|---|---|---|
|
Gender-Stratified, PostOperative Care Unit (PACU) Discharge Length of Stay Rate (Minutes) Between Sedline Brain Monitoring-Arm vs Control-Arm
|
82 minutes
Interval 66.0 to 100.0
|
89 minutes
Interval 70.0 to 109.0
|
82 minutes
Interval 66.0 to 100.0
|
89 minutes
Interval 70.0 to 109.0
|
Adverse Events
Control Arm
Sedline Monitor Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Guided Anesthetic Management Using Brain Function Monitoring in Young Adult Surgical Patients: A Ran
University of Chicago
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place