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Concern for volume depletion and electrolyte abnormalities in furosemide arm.
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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.
Rating of brain relaxation will be on a 4-point scale:
0 = brain very relaxed under dura, acceptable
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furosemide | Active Comparator | Furosemide 0.3 mg/kg |
|
| Placebo | Placebo Comparator | Up to 5 mL saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | Furosemide 0.3 mg/kg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptable vs. Unacceptable Brain Relaxation at Dural Opening | Rating of brain relaxation will be on a 4-point scale: 0 = brain very relaxed under dura, acceptable
| just prior to dural opening for each subject |
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Inclusion Criteria:
Inclusion criteria include:
Exclusion Criteria:
• ASA PS IV or V
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| Name | Affiliation | Role |
|---|---|---|
| John F Bebawy, MD | Northwestern University | Principal Investigator |
| Dhanesh K Gupta, MD | Northwestern University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11818776 | Background | 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. | |
| 17122580 | Background | 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. |
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23 patients enrolled sequentially, no dropouts
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| ID | Title | Description |
|---|---|---|
| FG000 | Furosemide | Furosemide : Furosemide 0.3 mg/kg |
| FG001 | Placebo | Placebo : Placebo (up to 5mL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Furosemide | Furosemide : Furosemide 0.3 mg/kg |
| BG001 | Placebo | Placebo : Placebo (up to 5mL) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptable vs. Unacceptable Brain Relaxation at Dural Opening | Rating of brain relaxation will be on a 4-point scale: 0 = brain very relaxed under dura, acceptable
| Posted | Mean | Standard Error | units on a scale 0-3 | just prior to dural opening for each subject |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Furosemide | Furosemide : Furosemide 0.3 mg/kg |
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Recruitment was stopped at 23 subjects because of concern that the administration of furosemide was producing such a large diuresis that clinically significant and potentially unsafe hypovolemia and electrolyte abnormalities were developing.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John F. Bebawy, Assistant Professor of Anesthesiology & Neurological Surgery | Northwestern University | 312-695-0061 | j-bebawy@northwestern.edu |
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| ID | Term |
|---|---|
| D001929 | Brain Edema |
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014883 | Water-Electrolyte Imbalance |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo (up to 5mL) |
|
|
| 6412595 | Background | 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. |
| 8512094 | Background | 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. |
| 18073543 | Background | 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. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Placebo | Placebo : Placebo (up to 5mL) | 0 | 13 | 0 | 13 |
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |