Recruiting

Mannitol & Hypertonic Saline

Sponsor:

Université de Sherbrooke

Code:

NCT01745081

Conditions

Osmotherapy

Intracranial Pressure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

20% mannitol bolus administration

Hypertonic saline 3% bolus administration

Study Details

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.

Conditions

Osmotherapy

Intracranial Pressure

Study ID

NCT01745081

Start date

Sep, 2012

Status verified date

Dec, 2012

Completion date

Sep, 2014

Anticipated

Primary completion date

Sep, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mannitol

Bolus mannitol 20% at skin incision

experimental: Hypertonic saline

Hypertonic saline 3% at skin incision

Interventions

20% mannitol bolus administration

Hypertonic saline 3% bolus administration

Primary outcome measure

  • Sub-dural intracranial pressure [ Time Frame: In average 30-60 minutes after intervention, just before dura mater opening ]

Central Contacts and Locations

Central contacts

Stéphane Coutu, MD, FRCPC

8193461110stephane.coutu@usherbrooke.ca

Locations

Centre hospitalier universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H5N4

Contacts

18193461110

More Information

Sponsor

Université de Sherbrooke

Last update posted

Dec 7, 2012

Last verified

Dec, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2012-12-07.