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

This study is currently recruiting participants.
Verified December 2012 by Universitaire de Sherbrooke
Sponsor:
Information provided by (Responsible Party):
Stéphane Coutu, Centre Hospitalier Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01745081
First received: December 5, 2012
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Osmotherapy
Intracranial Pressure
 Drug: 20% mannitol bolus administration
Drug: Hypertonic saline 3% bolus administration
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Mannitol
U.S. FDA Resources

Further study details as provided by Universitaire de Sherbrooke:

Primary Outcome Measures:
  • Sub-dural intracranial pressure [ Time Frame: In average 30-60 minutes after intervention, just before dura mater opening ] [ Designated as safety issue: No ]
    Sub-dural measure of intracranial pressure to evaluate cerebral relaxation


Secondary Outcome Measures:
  • Subjective evaluation of cerebral relaxation [ Time Frame: In average 30-60 minutes after intervention, just after dura mater opening ] [ Designated as safety issue: No ]
    Subjective evaluation by the surgeon of cerebral relaxation on a 4 point scale

  • Serum lactate [ Time Frame: In average 5-8 hours after intervention, upon arrival in the intensive care unit ] [ Designated as safety issue: Yes ]
    Serum lactate measurement to assess tissue perfusion during the procedure


Estimated Enrollment: 80
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745081

Contacts
Contact: Stéphane Coutu, MD, FRCPC 8193461110 ext 14950 stephane.coutu@usherbrooke.ca

Locations
Canada, Quebec
Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H5N4
Contact     18193461110        
Sponsors and Collaborators
Universitaire de Sherbrooke
  More Information

No publications provided

Responsible Party: Stéphane Coutu, Principal study investigator, Centre Hospitalier Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01745081     History of Changes
Other Study ID Numbers: Study on cerebral relaxation
Study First Received: December 5, 2012
Last Updated: December 6, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013