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

Sponsor

Université de Sherbrooke (Other)

Overall Status

Unknown status

CT.gov ID

NCT01745081

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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.

Study Start Date :

Sep 1, 2012

Anticipated Primary Completion Date :

Sep 1, 2014

Anticipated Study Completion Date :

Sep 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Sub-dural intracranial pressure [In average 30-60 minutes after intervention, just before dura mater opening]
Sub-dural measure of intracranial pressure to evaluate cerebral relaxation

Secondary Outcome Measures

Subjective evaluation of cerebral relaxation [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
Serum lactate [In average 5-8 hours after intervention, upon arrival in the intensive care unit]
Serum lactate measurement to assess tissue perfusion during the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec	Canada	J1H5N4

Sponsors and Collaborators

Université de Sherbrooke

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stéphane Coutu, Principal study investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

ClinicalTrials.gov Identifier:

NCT01745081

Other Study ID Numbers:

Study on cerebral relaxation

First Posted:

Dec 7, 2012

Last Update Posted:

Dec 7, 2012

Last Verified:

Dec 1, 2012

Additional relevant MeSH terms:

Mannitol

Study Results

No Results Posted as of Dec 7, 2012