Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intracranial Pressure | — | UNRESOLVED | — |
| Osmotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 20% mannitol bolus administration | Drug | — | UNRESOLVED |
| Hypertonic saline 3% bolus administration | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mannitol
- description
- Bolus mannitol 20% at skin incision
- interventionNames
- Drug: 20% mannitol bolus administration
- type
- EXPERIMENTAL
- label
- Hypertonic saline
- description
- Hypertonic saline 3% at skin incision
- interventionNames
- Drug: Hypertonic saline 3% bolus administration
Primary outcomes (1)
- measure
- Sub-dural intracranial pressure
- timeFrame
- In average 30-60 minutes after intervention, just before dura mater opening
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available