Furosemide vs Placebo for Brain Relaxation

Dehydration Clinical Trial

Official title:

The Effect of Furosemide Versus Placebo on Brain Relaxation and Incidence of Significant Intravascular Volume Depletion in Human Subjects Receiving Mannitol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01054404
• Other study ID #: STU00016126
• Status: Terminated
• Phase: N/A
• First received: January 20, 2010
• Last updated: June 27, 2013
• Start date: February 2010
• Est. completion date: March 2012

Study information

• Verified date: June 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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 information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Edema
• Brain Swelling
• Dehydration

Intervention

Drug:
• Furosemide
Furosemide 0.3 mg/kg
• Placebo
Placebo (up to 5mL)

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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; = brain adequately relaxed under dura, acceptable; = brain slightly tense under dura, acceptable; = brain very tense under bulging dura, unacceptable	just prior to dural opening for each subject	No