Furosemide vs Placebo for Brain Relaxation
Increased brain bulk may be problematic during brain surgery for tumors because it may limit surgical exposure and access to the surgical site. Mannitol, an osmotic diuretic, is commonly given to alleviate brain bulk, and sometimes furosemide in a small dose is added if mannitol alone is insufficient. It is unclear if adding this furosemide truly helps to diminish brain bulk, and it is possible that furosemide may cause too much diuresis, leading to dehydration and its side effects (e.g., low blood pressure). Our purpose is to investigate what the effects of furosemide are in the setting of brain surgery for tumors, specifically with regards to decreasing brain bulk and/or causing dehydration. Study Hypothesis: The addition of furosemide to mannitol will result in improved brain relaxation in human subjects undergoing craniotomy for brain tumor resection than that seen with mannitol alone. However, the combination of mannitol and furosemide will also lead to more significant intravascular volume depletion than that seen with mannitol alone.
Full Title of Study: “The Effect of Furosemide Versus Placebo on Brain Relaxation and Incidence of Significant Intravascular Volume Depletion in Human Subjects Receiving Mannitol”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: March 2012
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
- Drug: Furosemide
- Furosemide 0.3 mg/kg
- Drug: Placebo
- Placebo (up to 5mL)
Arms, Groups and Cohorts
- Active Comparator: Furosemide
- Furosemide 0.3 mg/kg
- Placebo Comparator: Placebo
- Up to 5 mL saline
Clinical Trial Outcome Measures
- Acceptable vs. Unacceptable Brain Relaxation at Dural Opening
- Time Frame: just prior to dural opening for each subject
- Rating of brain relaxation will be on a 4-point scale: 0 = brain very relaxed under dura, acceptable = brain adequately relaxed under dura, acceptable = brain slightly tense under dura, acceptable = brain very tense under bulging dura, unacceptable
Participating in This Clinical Trial
Inclusion criteria include:
- ASA PS I-III – Age 18 or older – Presenting for elective resection of primary or metastatic supratentorial brain tumor(s) Exclusion Criteria:
- • ASA PS IV or V – Age less than 18 – Emergency surgery due to severely elevated ICP/impending brainstem herniation – Concurrent use of diuretics for any indication – Infratentorial/posterior fossa/cerebellar tumor resection – Moderate/severe cardiac disease with limitation in contractility as measured by preoperative echocardiogram (EF < 30%) – Severe pulmonary hypertension as measured and/or observed by preoperative studies – Preoperative use of steroids (within 6 months, including those on standing doses) – Pregnancy
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Northwestern University
- Provider of Information About this Clinical Study
- Principal Investigator: John Bebawy, Assistant Professor of Anesthesiology & Neurological Surgery – Northwestern University
- Overall Official(s)
- John F Bebawy, MD, Principal Investigator, Northwestern University
- Dhanesh K Gupta, MD, Study Director, Northwestern University
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