Furosemide vs Placebo for Brain Relaxation

NCT01054404 | Terminated Results

• 1 other identifier: STU00016126
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Swelling; Brain Edema; Dehydration

Keywords

Brain Swelling; Brain Edema; Dehydration

Outcome Measures

Primary Outcomes (1)

• 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 1. = brain adequately relaxed under dura, acceptable 2. = brain slightly tense under dura, acceptable 3. = brain very tense under bulging dura, unacceptable

  just prior to dural opening for each subject

Study Arms (2)

Furosemide

ACTIVE COMPARATOR

Furosemide 0.3 mg/kg

Drug: Furosemide

Placebo

PLACEBO COMPARATOR

Up to 5 mL saline

Drug: Placebo

Interventions

Furosemide DRUG

Furosemide 0.3 mg/kg

Also known as: Lasix

Furosemide

Placebo DRUG

Placebo (up to 5mL)

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA PS I-III
• Age 18 or older
• Presenting for elective resection of primary or metastatic supratentorial brain tumor(s)

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

• 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.

  PMID: 11818776 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.

  PMID: 17122580 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.

  PMID: 6412595 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.

  PMID: 8512094 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.

  PMID: 18073543 BACKGROUND

MeSH Terms

Conditions

Brain Edema; Dehydration

Interventions

Furosemide; Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. John F. Bebawy, Assistant Professor of Anesthesiology & Neurological Surgery
• Organization: Northwestern University

j-bebawy@northwestern.edu

312-695-0061

Study Officials

• John F Bebawy, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Dhanesh K Gupta, MD

  Northwestern University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology & Neurological Surgery

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 22, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 2, 2013
• Results First Posted: August 2, 2013

Record last verified: 2013-06

Locations

US (1)