Trials / Unknown
UnknownNCT02168075
Mannitol Brain Relaxation Effect
Can Mannitol Increments Provide More Brain Relaxation in Patients Undergoing Craniotomy for Supratentorial Brain Tumor Removal?
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
| 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). |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2016-05-01
- First posted
- 2014-06-20
- Last updated
- 2014-10-24
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02168075. Inclusion in this directory is not an endorsement.