Study Results
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View full resultsBasic Information
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TERMINATED
NA
23 participants
INTERVENTIONAL
2010-02-28
2012-03-31
Brief Summary
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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.
Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Furosemide
Furosemide 0.3 mg/kg
Furosemide
Furosemide 0.3 mg/kg
Placebo
Up to 5 mL saline
Placebo
Placebo (up to 5mL)
Interventions
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Furosemide
Furosemide 0.3 mg/kg
Placebo
Placebo (up to 5mL)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 or older
* Presenting for elective resection of primary or metastatic supratentorial brain tumor(s)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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John Bebawy
Assistant Professor of Anesthesiology & Neurological Surgery
Principal Investigators
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John F Bebawy, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Dhanesh K Gupta, MD
Role: STUDY_DIRECTOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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References
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Thenuwara K, Todd MM, Brian JE Jr. Effect of mannitol and furosemide on plasma osmolality and brain water. Anesthesiology. 2002 Feb;96(2):416-21. doi: 10.1097/00000542-200202000-00029.
Todd MM, Cutkomp J, Brian JE. Influence of mannitol and furosemide, alone and in combination, on brain water content after fluid percussion injury. Anesthesiology. 2006 Dec;105(6):1176-81. doi: 10.1097/00000542-200612000-00017.
Rudehill A, Lagerkranser M, Lindquist C, Gordon E. Effects of mannitol on blood volume and central hemodynamics in patients undergoing cerebral aneurysm surgery. Anesth Analg. 1983 Oct;62(10):875-80.
Todd MM, Warner DS, Sokoll MD, Maktabi MA, Hindman BJ, Scamman FL, Kirschner J. A prospective, comparative trial of three anesthetics for elective supratentorial craniotomy. Propofol/fentanyl, isoflurane/nitrous oxide, and fentanyl/nitrous oxide. Anesthesiology. 1993 Jun;78(6):1005-20. doi: 10.1097/00000542-199306000-00002.
Rozet I, Tontisirin N, Muangman S, Vavilala MS, Souter MJ, Lee LA, Kincaid MS, Britz GW, Lam AM. Effect of equiosmolar solutions of mannitol versus hypertonic saline on intraoperative brain relaxation and electrolyte balance. Anesthesiology. 2007 Nov;107(5):697-704. doi: 10.1097/01.anes.0000286980.92759.94.
Other Identifiers
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STU00016126
Identifier Type: -
Identifier Source: org_study_id