Supratentorial Neoplasms
Conditions
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.
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.
Interventions
DRUG0.25g/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).
DRUG0.5g/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).
DRUG1.0g/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).
DRUG1.5g/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).
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| brain parenchymal relaxation | 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
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic change | 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. |
| Electrolyte change | 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. |
| Urine output | 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. |
| Osmolar gap change | 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) |
| Brain relaxation score | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Arterial blood gas analysis (ABGA) change | 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. |
Countries
South Korea
Contacts
Primary ContactHee Pyung Park, MD PhD
Backup ContactEugene Kim, MD
Outcome results
None listed