A Phase 4 interventional study of 20% mannitol bolus administration and Hypertonic saline 3% bolus administration in Osmotherapy and Intracranial Pressure, sponsored by Université de Sherbrooke. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-07.
Sponsored by Université de Sherbrooke · Phase 4, Interventional, and Treatment
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.
Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bolus mannitol 20% at skin incision
Drug: 20% mannitol bolus administration
Hypertonic saline 3% at skin incision
Drug: Hypertonic saline 3% bolus administration
Sub-dural intracranial pressure
Sub-dural measure of intracranial pressure to evaluate cerebral relaxation
Time frame: In average 30-60 minutes after intervention, just before dura mater opening
Subjective evaluation of cerebral relaxation
Subjective evaluation by the surgeon of cerebral relaxation on a 4 point scale
Time frame: In average 30-60 minutes after intervention, just after dura mater opening
Serum lactate
Serum lactate measurement to assess tissue perfusion during the procedure
Time frame: In average 5-8 hours after intervention, upon arrival in the intensive care unit
This study is status unknown, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Université de Sherbrooke