Trial Outcomes & Findings for Furosemide vs Placebo for Brain Relaxation (NCT NCT01054404)

Last Updated: 2013-08-02

Results Overview

Rating of brain relaxation will be on a 4-point scale: 0 = brain very relaxed under dura, acceptable 1. = brain adequately relaxed under dura, acceptable 2. = brain slightly tense under dura, acceptable 3. = brain very tense under bulging dura, unacceptable

Recruitment status

TERMINATED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

just prior to dural opening for each subject

Results posted on

2013-08-02

Participant Flow

23 patients enrolled sequentially, no dropouts

Participant milestones

Participant milestones
Measure	Furosemide Furosemide : Furosemide 0.3 mg/kg	Placebo Placebo : Placebo (up to 5mL)
Overall Study STARTED	10	13
Overall Study COMPLETED	10	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Furosemide vs Placebo for Brain Relaxation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Furosemide n=10 Participants Furosemide : Furosemide 0.3 mg/kg	Placebo n=13 Participants Placebo : Placebo (up to 5mL)	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age Continuous	51 years STANDARD_DEVIATION 16.6 • n=5 Participants	52.1 years STANDARD_DEVIATION 15.6 • n=7 Participants	51.6 years STANDARD_DEVIATION 15.7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	13 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: just prior to dural opening for each subject

Outcome measures

Outcome measures
Measure	Furosemide n=10 Participants Furosemide : Furosemide 0.3 mg/kg	Placebo n=13 Participants Placebo : Placebo (up to 5mL)
Acceptable vs. Unacceptable Brain Relaxation at Dural Opening	1.5 units on a scale 0-3 Standard Error .17	1.3 units on a scale 0-3 Standard Error .13

Adverse Events

Furosemide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. John F. Bebawy, Assistant Professor of Anesthesiology & Neurological Surgery

Northwestern University

Phone: 312-695-0061

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place