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

NCT ID: NCT01745081

Last Updated: 2012-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osmotherapy Intracranial Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mannitol

Bolus mannitol 20% at skin incision

Group Type EXPERIMENTAL

20% mannitol bolus administration

Intervention Type DRUG

Hypertonic saline

Hypertonic saline 3% at skin incision

Group Type EXPERIMENTAL

Hypertonic saline 3% bolus administration

Intervention Type DRUG

Interventions

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20% mannitol bolus administration

Intervention Type DRUG

Hypertonic saline 3% bolus administration

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Stéphane Coutu

Principal study investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Stéphane Coutu, MD, FRCPC

Role: CONTACT

Phone: 8193461110

Email: [email protected]

Facility Contacts

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Role: primary

Other Identifiers

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Study on cerebral relaxation

Identifier Type: -

Identifier Source: org_study_id