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

Université de Sherbrooke80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Osmotherapy Intracranial Pressure

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Sub-dural intracranial pressure

Sub-dural measure of intracranial pressure to evaluate cerebral relaxation

Time frame: In average 30-60 minutes after intervention, just before dura mater opening

Secondary Outcomes

Subjective evaluation of cerebral relaxation

Subjective evaluation by the surgeon of cerebral relaxation on a 4 point scale

Time frame: In average 30-60 minutes after intervention, just after dura mater opening

Serum lactate

Serum lactate measurement to assess tissue perfusion during the procedure

Time frame: In average 5-8 hours after intervention, upon arrival in the intensive care unit