Comparison of the Efficacy Between 20% Mannitol and 3% Hypertonic Saline, Given as a Bolus at the Beginning of Elective Supratentorial Craniotomy for Tumor Resection, in Favoring Cerebral Relaxation Evaluated by a Sub-dural Intracranial Pressure Measurement.
18 Years
N/A
Both
Osmotherapy, Intracranial Pressure
Trial Information
Comparison of the Efficacy Between 20% Mannitol and 3% Hypertonic Saline, Given as a Bolus at the Beginning of Elective Supratentorial Craniotomy for Tumor Resection, in Favoring Cerebral Relaxation Evaluated by a Sub-dural Intracranial Pressure Measurement.
Inclusion Criteria:
- Patients scheduled for elective supratentorial craniotomy for tumor resection
- Presumed preoperative diagnosis of : astrocytoma (any grade), meningioma (any
sub-type) or cerebral metastasis (any primary neoplasm)
Exclusion Criteria:
- Age < 18 years
- Reintervention
- Glasgow coma scale < 13
- Emergency surgery or American Association of Anesthesiologists physical status class
4 or 5
- Prone or lateral positioning
- Hypo or hypernatremia (serum sodium below 135 or above 150 meq/L)
- Osmotherapy (either mannitol or hypertonic saline) given in the last 24 hours
- Congestive heart failure (LVEF < 40% or restrictive diastolic dysfunction on
echocardiography)
- Chronic renal failure (creatinine clearance < 30 ml/min)
- Pregnancy
- Obesity (BMI > 40)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Sub-dural intracranial pressure
Outcome Description:
Sub-dural measure of intracranial pressure to evaluate cerebral relaxation
Outcome Time Frame:
In average 30-60 minutes after intervention, just before dura mater opening
Safety Issue:
No
Authority:
Canada: Ethics Review Committee
Study ID:
Study on cerebral relaxation
NCT ID:
NCT01745081
Start Date:
September 2012
Completion Date:
September 2014
Related Keywords:
- Osmotherapy
- Intracranial Pressure
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