Brain Relaxation With Mannitol and Furosemide

NCT02712476 | Completed

• 1 other identifier: Cerrahpasa Neuroanesthesia
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

Although mannitol is used for brain relaxation during neurosurgery and in the treatment of raised intracranial pressure; there is not a consensus on its safe and effective dose, the duration of its administration and its use in combination with loop diuretics. This study aimed to compare the effects of the mannitol alone and in combination with furosemide in different doses, on the brain relaxation, electrolyte, lactate levels of the blood, peroperative fluid balance and the volume of the urine in supratentorial mass resection surgeries. This prospective, randomized, double blind, placebo controlled study included fifty one patients (ASA I-III) scheduled for elective supratentorial mass resection surgery. The patients were randomized into three groups for investigation of the effects of mannitol alone and in combination with furosemide in different doses. Blood sodium, potassium, chlorine, lactate, urine and osmolarity levels were recorded. The brain relaxation score (BRS) was evaluated twice by the surgeon using a 4 point scale (1=very good, 2=good, 3=bad, 4=very bad); at dura opening, and 30 minutes after the administration of the study drug.

Conditions

Brain Tumors

Keywords

Mannitol; Furosemid; Brain Relaxation

Outcome Measures

Primary Outcomes (1)

• brain relaxation score

  evaluated by surgical team using 4 point scale (1= very good, 2= good, 3= bad, 4= very bad)

  Change in brain relaxation in 30 minutes after drug administration

Secondary Outcomes (6)

• Blood sodium levels (mEq/L)

  change in 30 minute intervals in the first 2 hour and then again in the 6th, 12th and 24th hours after study drug administration

• Blood potassium levels (mEq/L)

  change in 30 minute intervals in the first 2 hour and then again in the 6th, 12th and 24th hours after study drug administration

• Blood chlorine levels (mEq/L)

  change in 30 minute intervals in the first 2 hour and then again in the 6th, 12th and 24th hours after study drug administration

• Blood lactate levels (mmol/L)

  change in 30 minute intervals in the first 2 hour and then again in the 6th, 12th and 24th hours after study drug administration

• 24 hours diuresis (mL)

  change in 24th hours after study drug administration

Study Arms (2)

Mannitol,furosemide

ACTIVE COMPARATOR

Mannitol 0.5mg/kg and furosemide 0.5mg/kg IV is compared with mannitol 1mg/kg and furosemide 0.5mg/kg

Drug: mannitol; Drug: Furosemide

Mannitol, placebo

PLACEBO COMPARATOR

Mannitol 0.5mg/kg and placebo is compared with mannitol+forosemide

Drug: mannitol; Drug: placebo

Interventions

mannitol DRUG

This drug is in our routine use of neuroanesthesia, are given in peroperatifyl brain relaxation

Mannitol, placebo; Mannitol,furosemide

Furosemide DRUG

This drug is can be used alone or with mannitol for brain relaxation

Also known as: Lasix

Mannitol,furosemide

placebo DRUG

mannitol alone is compared with placebo

Mannitol, placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intracranial shift
• Scheduled for supratentorial mass resection under elective conditions

You may not qualify if:

• Decompensated heart failure
• kidney insufficiency
• Diabetes insipidus,
• Electrolyte imbalance and
• Who are unconscious

Sponsors & Collaborators

• Istanbul University: lead

Related Publications (14)

• Vialet R, Leone M, Albanese J, Martin C. Calculated serum osmolality can lead to a systematic bias compared to direct measurement. J Neurosurg Anesthesiol. 2005 Apr;17(2):106-9. doi: 10.1097/01.ana.0000163200.48483.56.

  PMID: 15840998 BACKGROUND

• Bebawy JF, Ramaiah VK, Zeeni C, Hemmer LB, Koht A, Gupta DK. The effect of furosemide on intravascular volume status and electrolytes in patients receiving mannitol: an intraoperative safety analysis. J Neurosurg Anesthesiol. 2013 Jan;25(1):51-4. doi: 10.1097/ANA.0b013e318269c335.

  PMID: 23237936 RESULT

• Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. XV. Steroids. J Neurotrauma. 2007;24 Suppl 1:S91-5. doi: 10.1089/neu.2007.9981. No abstract available.

  PMID: 17511554 RESULT

• Li Q, Chen H, Hao JJ, Yin NN, Xu M, Zhou JX. Agreement of measured and calculated serum osmolality during the infusion of mannitol or hypertonic saline in patients after craniotomy: a prospective, double-blinded, randomised controlled trial. BMC Anesthesiol. 2015 Oct 7;15:138. doi: 10.1186/s12871-015-0119-4.

  PMID: 26445777 RESULT

• Manninen PH, Lam AM, Gelb AW, Brown SC. The effect of high-dose mannitol on serum and urine electrolytes and osmolality in neurosurgical patients. Can J Anaesth. 1987 Sep;34(5):442-6. doi: 10.1007/BF03014345.

  PMID: 3117392 RESULT

• Pollay M, Fullenwider C, Roberts PA, Stevens FA. Effect of mannitol and furosemide on blood-brain osmotic gradient and intracranial pressure. J Neurosurg. 1983 Dec;59(6):945-50. doi: 10.3171/jns.1983.59.6.0945.

  PMID: 6415245 RESULT

• Procaccio F, Stocchetti N, Citerio G, Berardino M, Beretta L, Della Corte F, D'Avella D, Brambilla GL, Delfini R, Servadei F, Tomei G. Guidelines for the treatment of adults with severe head trauma (part II). Criteria for medical treatment. J Neurosurg Sci. 2000 Mar;44(1):11-8.

  PMID: 10961491 RESULT

• Procaccio F, Stocchetti N, Citerio G, Berardino M, Beretta L, Della Corte F, D'Avella D, Brambilla GL, Delfini R, Servadei F, Tomei G. Guidelines for the treatment of adults with severe head trauma (part I). Initial assessment; evaluation and pre-hospital treatment; current criteria for hospital admission; systemic and cerebral monitoring. J Neurosurg Sci. 2000 Mar;44(1):1-10.

  PMID: 10961490 RESULT

• Quentin C, Charbonneau S, Moumdjian R, Lallo A, Bouthilier A, Fournier-Gosselin MP, Bojanowski M, Ruel M, Sylvestre MP, Girard F. A comparison of two doses of mannitol on brain relaxation during supratentorial brain tumor craniotomy: a randomized trial. Anesth Analg. 2013 Apr;116(4):862-8. doi: 10.1213/ANE.0b013e318282dc70. Epub 2013 Jan 25.

  PMID: 23354336 RESULT

• 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 RESULT

• Schettini A, Stahurski B, Young HF. Osmotic and osmotic-loop diuresis in brain surgery. Effects on plasma and CSF electrolytes and ion excretion. J Neurosurg. 1982 May;56(5):679-84. doi: 10.3171/jns.1982.56.5.0679.

  PMID: 6802937 RESULT

• 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 RESULT

• 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 RESULT

• Akcil EF, Dilmen OK, Karabulut ES, Koksal SS, Altindas F, Tunali Y. Effective and safe mannitol administration in patients undergoing supratentorial tumor surgery: A prospective, randomized and double blind study. Clin Neurol Neurosurg. 2017 Aug;159:55-61. doi: 10.1016/j.clineuro.2017.05.018. Epub 2017 May 15.

  PMID: 28544917 DERIVED

Related Links

• test link

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Mannitol; Furosemide

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Sulfanilamides; Sulfonamides; Amides; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 18, 2016
• Study Start: July 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 18, 2016

Record last verified: 2016-03