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

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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01745081

Enrollment

Registered

2012-12-07

Start date

2012-09-30

Completion date

2014-09-30

Last updated

2012-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Pressure, Osmotherapy

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.

Interventions

DRUG20% mannitol bolus administration

DRUGHypertonic saline 3% bolus administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Canada

Contacts

Primary ContactStéphane Coutu, MD, FRCPC

stephane.coutu@usherbrooke.ca8193461110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026