Mannitol Brain Relaxation Effect
MANNITOL
Can Mannitol Increments Provide More Brain Relaxation in Patients Undergoing Craniotomy for Supratentorial Brain Tumor Removal?
1 other identifier
interventional
124
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 16, 2014
CompletedFirst Posted
Study publicly available on registry
June 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedOctober 24, 2014
October 1, 2014
1.9 years
June 16, 2014
October 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
brain parenchymal relaxation
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.
intraoperative
Secondary Outcomes (5)
Hemodynamic change
at baseline, 30 min, 60min and 180 min after the administration of the study drug
Electrolyte change
at baseline, 30 min, 60min and 180 min after the administration of the study drug
Brain relaxation score
intraoperative
Urine output
at just after induction of anesthesia, 30min, 60min and 180 min after mannitl loading
Osmolar gap change
at baseline, 30min, 60min and 180 min after the administration of the study drug
Other Outcomes (1)
Arterial blood gas analysis (ABGA) change
at baseline, 30min, 60min and 180 min after the administration of the study drug
Study Arms (4)
Group 1
EXPERIMENTAL0.25g/kgof 20% mannitol administered at drilling of skull.
Group 2
EXPERIMENTAL0.5g/kg of 20% mannitol administered at drilling of skull.
Group 3
EXPERIMENTAL1.0 g/kg of 20% mannitol administered at drilling of skull.
Group 4
EXPERIMENTAL1.5g/kg of 20% mannitol administered at drilling of skull.
Interventions
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).
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).
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).
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).
Eligibility Criteria
You may qualify if:
- Patients who underwent craniotomy for supratentorial brain tumor under general anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University of Hospital
Seoul, 110-799, South Korea
Related Publications (1)
Seo H, Kim E, Jung H, Lim YJ, Kim JW, Park CK, Se YB, Jeon YT, Hwang JW, Park HP. A prospective randomized trial of the optimal dose of mannitol for intraoperative brain relaxation in patients undergoing craniotomy for supratentorial brain tumor resection. J Neurosurg. 2017 Jun;126(6):1839-1846. doi: 10.3171/2016.6.JNS16537. Epub 2016 Aug 19.
PMID: 27540904DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hee Pyung Park, MD PhD
Professor
- PRINCIPAL INVESTIGATOR
Eugene Kim, MD
Clinical Instuctor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 16, 2014
First Posted
June 20, 2014
Study Start
June 1, 2014
Primary Completion
May 1, 2016
Last Updated
October 24, 2014
Record last verified: 2014-10