Trial Outcomes & Findings for A Comparison of Propofol Versus Midazolam to Sedate Critically Brain Injury; Measurement of Cytokine Response and Assessment of Function (NCT NCT01712477)

Results Overview

Extent of functional deficits from underlying traumatic brain injury

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

30 days

Results posted on

2025-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Intravenous Sedation With Propofol Traumatic brain injured patient, already requiring sedation. Intervention is sedation with intravenous propofol during mechanical ventilation Intravenous sedation using propofol: Patients will be given intravenous sedation for treatment of traumatic brain injury requiring mechanical ventilation
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Sedation With Propofol n=1 Participants Traumatic brain injured patient, already requiring sedation. Intervention is sedation with intravenous propofol during mechanical ventilation Intravenous sedation using propofol: Patients will be given intravenous sedation for treatment of traumatic brain injury requiring mechanical ventilation
Age, Categorical <=18 years	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=1 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants
Sex: Female, Male Female	0 Participants n=1 Participants
Sex: Female, Male Male	1 Participants n=1 Participants
Region of Enrollment United States	1 participants n=1 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Only one participant was enrolled and data analysis was not completed

Extent of functional deficits from underlying traumatic brain injury

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Population: Only one participant was enrolled and data analysis was not completed.

cytokine levels will be measured to see if there is meaningful correlation between groups. unable to correlate due to closure of study

Outcome measures

Outcome data not reported

Adverse Events

Intravenous Sedation With Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chet A Morrison, M.D.

Michigan State University

Phone: 9897901001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place