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

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.

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 Overview

• Status: Unknown
• Conditions: Intracranial Pressure; Osmotherapy
• Intervention / Treatment: Drug: 20% mannitol bolus administration; Drug: Hypertonic saline 3% bolus administration

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Stéphane Coutu, MD, FRCPC; Phone Number: 14950 8193461110; Email: stephane.coutu@usherbrooke.ca

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H5N4
      • Recruiting
      • Centre Hospitalier Universitaire de Sherbrooke
      • Contact: Phone Number: 18193461110

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mannitol; Bolus mannitol 20% at skin incision	Drug: 20% mannitol bolus administration
EXPERIMENTAL: Hypertonic saline; Hypertonic saline 3% at skin incision	Drug: Hypertonic saline 3% bolus administration

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ANTICIPATED): September 1, 2014
• Study Completion (ANTICIPATED): September 1, 2014

Study Registration Dates

• First Submitted: December 5, 2012
• First Submitted That Met QC Criteria: December 6, 2012
• First Posted (ESTIMATE): December 7, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 7, 2012
• Last Update Submitted That Met QC Criteria: December 6, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: Study on cerebral relaxation