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

Phase 4

• Conditions: Osmotherapy; Intracranial Pressure
• Interventions: Drug: 20% mannitol bolus administration; Drug: Hypertonic saline 3% bolus administration

• Registration Number: NCT01745081
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Status Verified: 2012-12
• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-06
• Last Update Submitted: 2012-12-06
• Study First Posted: 2012-12-07
• Last Update Posted: 2012-12-07
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mannitol	20% mannitol bolus administration	Bolus mannitol 20% at skin incision
Hypertonic saline	Hypertonic saline 3% bolus administration	Hypertonic saline 3% at skin incision

Primary Outcome Measures

Name	Time	Method
Sub-dural intracranial pressure	In average 30-60 minutes after intervention, just before dura mater opening	Sub-dural measure of intracranial pressure to evaluate cerebral relaxation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada