Comparison of 20% Mannitol and 3% Hypertonic Saline for Cerebral Relaxation During Elective Supratentorial Craniotomies

Study Overview
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Brief Summary
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Mannitol 20% has long been used to treat elevated intracranial hypertension in trauma and intensive care settings. More recent data indicate that hypertonic saline may be as effective or more effective than mannitol for this purpose, with possible fewer side effects. This study compares both agents in favoring cerebral relaxation during elective supratentorial procedures for tumor resection. Study hypothesis: 3% hypertonic saline will provide better cerebral relaxation with fewer side effects than 20% mannitol.

Official Title
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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.

Conditions
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Osmotherapy, Intracranial Pressure

Intervention / Treatment
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* Drug: 20% mannitol bolus administration
* Drug: Hypertonic saline 3% bolus administration


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mannitol<br>Bolus mannitol 20% at skin incision | Drug: 20% mannitol bolus administration<br> <br> |
| Experimental: Hypertonic saline<br>Hypertonic saline 3% at skin incision | Drug: Hypertonic saline 3% bolus administration<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sub-dural intracranial pressure | Sub-dural measure of intracranial pressure to evaluate cerebral relaxation | In average 30-60 minutes after intervention, just before dura mater opening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective evaluation of cerebral relaxation | Subjective evaluation by the surgeon of cerebral relaxation on a 4 point scale | In average 30-60 minutes after intervention, just after dura mater opening | 
| Serum lactate | Serum lactate measurement to assess tissue perfusion during the procedure | In average 5-8 hours after intervention, upon arrival in the intensive care unit |