Trial Outcomes & Findings for The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury (NCT NCT03575169)
NCT ID: NCT03575169
Last Updated: 2026-08-10
Results Overview
Mean BIS of patients sedated. BIS is a processed EEG value ranging from 0 to 100, with lower values representing decreased brain activity. The usual range for General Anaesthesia is 40-60.
COMPLETED
26 participants
24 hours
2026-08-10
Participant Flow
Participant milestones
| Measure |
Patients With TBI
Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.
BIS Monitor: Unilateral BIS electrode
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients With TBI
n=26 Participants
Admitted to ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.
BIS Monitor: Unilateral BIS electrode
|
|---|---|
|
Age, Continuous
|
41 years
n=26 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: 24 hoursMean BIS of patients sedated. BIS is a processed EEG value ranging from 0 to 100, with lower values representing decreased brain activity. The usual range for General Anaesthesia is 40-60.
Outcome measures
| Measure |
Patients With TBI
n=26 Participants
Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.
BIS Monitor: Unilateral BIS electrode
|
|---|---|
|
Mean BIS for Population Over 24 Hours
|
38 BIS value (index)
Interval 29.0 to 44.0
|
SECONDARY outcome
Timeframe: 24 hoursMean ICP of sedated patients
Outcome measures
| Measure |
Patients With TBI
n=26 Participants
Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.
BIS Monitor: Unilateral BIS electrode
|
|---|---|
|
Mean ICP for Population Over 24 Hours
|
11 mmHg
Standard Deviation 6
|
SECONDARY outcome
Timeframe: 24 hoursNumber of instances of osmotherapy use in sedated patients
Outcome measures
| Measure |
Patients With TBI
n=26 Participants
Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.
BIS Monitor: Unilateral BIS electrode
|
|---|---|
|
Incidence of Osmotherapy Use for Population Over 24 Hours
|
35 Events
|
SECONDARY outcome
Timeframe: 24 hoursTotal vasopressor dose for sedated patients
Outcome measures
| Measure |
Patients With TBI
n=26 Participants
Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.
BIS Monitor: Unilateral BIS electrode
|
|---|---|
|
Median Vasopressor Dose for Population Over 24 Hours
|
0.11 mcg/kg/min
Interval 0.04 to 0.23
|
SECONDARY outcome
Timeframe: 24 hoursTotal sedative dose for sedated patients
Outcome measures
| Measure |
Patients With TBI
n=25 Participants
Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.
BIS Monitor: Unilateral BIS electrode
|
|---|---|
|
Sedative Dose for Population Over 24 Hours
|
1.95 mg/kg/hr
Interval 1.42 to 2.14
|
SECONDARY outcome
Timeframe: Days to weeksNumber of days admitted to ICU
Outcome measures
| Measure |
Patients With TBI
n=26 Participants
Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.
BIS Monitor: Unilateral BIS electrode
|
|---|---|
|
Length of ICU Stay for Population Over 24 Hours
|
18.2 days
Interval 7.25 to 21.25
|
Adverse Events
Patients With TBI
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place