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

December 6, 2012 updated by: Stéphane Coutu, Université de Sherbrooke

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: In average 30-60 minutes after intervention, just before dura mater opening
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
Time Frame: 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
In average 30-60 minutes after intervention, just after dura mater opening
Serum lactate
Time Frame: In average 5-8 hours after intervention, upon arrival in the intensive care unit
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

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • Study on cerebral relaxation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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