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Mannitol Brain Relaxation Effect (MANNITOL)

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ClinicalTrials.gov Identifier: NCT02168075
Recruitment Status : Unknown
Verified October 2014 by Hee-Pyoung Park, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : June 20, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Hee-Pyoung Park, Seoul National University Hospital

Brief Summary:
Mannitol is widely used in patients with elevated intracranial pressure. In neurosurgical field, especially in large size or with brain edema, it is necessary to decrease brain volume to facilitate surgical approach. In general, 0.25 -1.5g of mannitol per kilogram has been known to decrease ICP effectively. But there are some debates in regard to appropriate dose of mannitol.

Condition or disease Intervention/treatment Phase
Supratentorial Neoplasms Drug: 0.25g/kgof 20% mannitol Drug: 0.5g/kg of 20% mannitol Drug: 1.0g/kg of 20% mannitol Drug: 1.5g/kg of 20% mannitol Not Applicable

Detailed Description:

Previous meta-analysis reported that mannitol has dose-response relationship with intracranial pressure. Another study of Sorani showed dose-response relationship between mannitol and intracranial pressure (ICP) in traumatic brain injury patients.

In this study, authors would investigate that mannitol increments can provide more brain relaxation in patients undergoing craniotomy for supratentorial brain tumor removal.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Can Mannitol Increments Provide More Brain Relaxation in Patients Undergoing Craniotomy for Supratentorial Brain Tumor Removal?
Study Start Date : June 2014
Estimated Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Mannitol

Arm Intervention/treatment
Experimental: Group 1
0.25g/kgof 20% mannitol administered at drilling of skull.
Drug: 0.25g/kgof 20% mannitol
When the neurosurgeon starts the drilling of skull, 0.25g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).

Experimental: Group 2
0.5g/kg of 20% mannitol administered at drilling of skull.
Drug: 0.5g/kg of 20% mannitol
When the neurosurgeon starts the drilling of skull, 0.5g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).

Experimental: Group 3
1.0 g/kg of 20% mannitol administered at drilling of skull.
Drug: 1.0g/kg of 20% mannitol
When the neurosurgeon starts the drilling of skull, 1.0g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).

Experimental: Group 4
1.5g/kg of 20% mannitol administered at drilling of skull.
Drug: 1.5g/kg of 20% mannitol
When the neurosurgeon starts the drilling of skull,1.5g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).




Primary Outcome Measures :
  1. brain parenchymal relaxation [ Time Frame: intraoperative ]

    Brain relaxation was assessed immediately after opening of the dura on a scale range from 1 to 4 (1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed) by neurosurgeon who is blinded to dose of mannitol.

    3 and 4 scale means brain relaxed. We would analyse if the success proportion of brain relaxation increase according to the mannitol increment 0.25g/kg, 0.5g/kg, 1.0g/kg and 1.5g/kg using Cochran-Armitage trend test.



Secondary Outcome Measures :
  1. Hemodynamic change [ Time Frame: at baseline, 30 min, 60min and 180 min after the administration of the study drug ]
    Check the mean arterial blood pressure (ABP), heart rate (HR), central venous pressure (CVP) at baseline, 30min, 60min, and 180 min after skin incision. Baseline value means data of just after anesthetic induction.

  2. Electrolyte change [ Time Frame: at baseline, 30 min, 60min and 180 min after the administration of the study drug ]
    Check the serum laboratory result of electrolyte include potassium, sodium immediately before the infusion of mannitol and 30, 60 and 180 min after the administration of the study drug.

  3. Brain relaxation score [ Time Frame: intraoperative ]
    Brain relaxation was assessed immediately after opening of the dura on a scale range from 1 to 4 (1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed) by neurosurgeon who is blinded to dose of mannitol.

  4. Urine output [ Time Frame: at just after induction of anesthesia, 30min, 60min and 180 min after mannitl loading ]
    check the urine amount at baseline (just after induction of anesthesia), 30min/60min/180min after mannitol loading.

  5. Osmolar gap change [ Time Frame: at baseline, 30min, 60min and 180 min after the administration of the study drug ]

    Check the serum osmolarity, blood urea nitrogen (BUN), glucose immediately before the infusion of mannitol and 30, 60, and 180 minutes after the administration of the study drug for calculate the osmolar gap.

    Osmolar gap (OG) = measured osmolarity - calculated osmolarity Calculated osmolarity = 2x[Na(mMol)]+1.15x([glucose(mg/dL)/18)+([urea(mg/dL)/2.8)



Other Outcome Measures:
  1. Arterial blood gas analysis (ABGA) change [ Time Frame: at baseline, 30min, 60min and 180 min after the administration of the study drug ]
    Check the arterial blood gas analysis include (pH, PaCO2, PaO2, lactate and hematocrit) immediately before the infusion of mannitol and 30, 60, and 180 minutes after the administration of the study drug.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who underwent craniotomy for supratentorial brain tumor under general anesthesia

Exclusion Criteria:

  • Patient who does not agree to the study
  • Patients with or American Society of Anesthesiologists (ASA) physical status class IV or more
  • Patients with glasgow coma scale (GCS) under 13 points
  • Patients who have hyponatremia or hypernatremia (Na<130 or >150mEq/L)
  • Patients who have congestive heart failure or moderately decreased renal function (GFR <60ml/min/1.73m2)
  • Patients with extraventricular drainage such as external ventricular drain (EVD) or ventriculoperitoneal (VP) shunt
  • Patients who already under mannitolization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168075


Contacts
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Contact: Hee Pyung Park, MD PhD 82-2-2072-2466 hppark@snu.ac.kr
Contact: Eugene Kim, MD 82-2-2072-3108 tomomie@hanmail.net

Locations
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Korea, Republic of
Seoul National University of Hospital Recruiting
Seoul, Korea, Republic of, 110-799
Contact: Hee Pyung Park, MD PhD    82-2-2072-2466    hppark@snu.ac.kr   
Contact: Eugene Kim, MD    82-2-2072-3108    tomomie@hanmail.net   
Principal Investigator: Eugene Kim, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Hee Pyung Park, MD PhD Professor
Principal Investigator: Eugene Kim, MD Clinical Instuctor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hee-Pyoung Park, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02168075     History of Changes
Other Study ID Numbers: Mannitol
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs