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Trial record 32 of 244 for:    furosemide

Brain Relaxation With Mannitol and Furosemide

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ClinicalTrials.gov Identifier: NCT02712476
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : March 18, 2016
Sponsor:
Information provided by (Responsible Party):
Eren Fatma Akcil, Istanbul University

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.


Condition or disease Intervention/treatment Phase
Brain Tumors Drug: mannitol Drug: Furosemide Drug: placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Mannitol Alone Versus Different Doses of Mannitol in Combination With Furosemide on Brain Relaxation in Supratentorial Mass Resection Surgery
Study Start Date : July 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mannitol,furosemide
Mannitol 0.5mg/kg and furosemide 0.5mg/kg IV is compared with mannitol 1mg/kg and furosemide 0.5mg/kg
Drug: mannitol
This drug is in our routine use of neuroanesthesia, are given in peroperatifyl brain relaxation

Drug: Furosemide
This drug is can be used alone or with mannitol for brain relaxation
Other Name: Lasix

Placebo Comparator: Mannitol, placebo
Mannitol 0.5mg/kg and placebo is compared with mannitol+forosemide
Drug: mannitol
This drug is in our routine use of neuroanesthesia, are given in peroperatifyl brain relaxation

Drug: placebo
mannitol alone is compared with placebo




Primary Outcome Measures :
  1. brain relaxation score [ Time Frame: Change in brain relaxation in 30 minutes after drug administration ]
    evaluated by surgical team using 4 point scale (1= very good, 2= good, 3= bad, 4= very bad)


Secondary Outcome Measures :
  1. Blood sodium levels (mEq/L) [ Time Frame: change in 30 minute intervals in the first 2 hour and then again in the 6th, 12th and 24th hours after study drug administration ]
  2. Blood potassium levels (mEq/L) [ Time Frame: change in 30 minute intervals in the first 2 hour and then again in the 6th, 12th and 24th hours after study drug administration ]
  3. Blood chlorine levels (mEq/L) [ Time Frame: change in 30 minute intervals in the first 2 hour and then again in the 6th, 12th and 24th hours after study drug administration ]
  4. Blood lactate levels (mmol/L) [ Time Frame: change in 30 minute intervals in the first 2 hour and then again in the 6th, 12th and 24th hours after study drug administration ]
  5. 24 hours diuresis (mL) [ Time Frame: change in 24th hours after study drug administration ]
  6. Fluid balance during operation (mL) [ Time Frame: Change in balance during operation time ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Additional Information:
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eren Fatma Akcil, MD, Istanbul University
ClinicalTrials.gov Identifier: NCT02712476     History of Changes
Other Study ID Numbers: Cerrahpasa Neuroanesthesia
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Eren Fatma Akcil, Istanbul University:
Mannitol
Furosemid
Brain Relaxation
Additional relevant MeSH terms:
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Furosemide
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mannitol
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Diuretics, Osmotic