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

Intracranial Pressure Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01745081
• Other study ID #: Study on cerebral relaxation
• Status: Recruiting
• Phase: Phase 4
• First received: December 5, 2012
• Last updated: December 6, 2012
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: December 2012
• Source: Université de Sherbrooke
• Contact: Stéphane Coutu, MD, FRCPC
• Phone: 8193461110
• Email: stephane.coutu[@]usherbrooke.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Intracranial Pressure
• Osmotherapy

Intervention

Drug:
• 20% mannitol bolus administration

• Hypertonic saline 3% bolus administration

Locations

Country	Name	City	State
Canada	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes