Acta neurochirurgica. Supplement
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Acta Neurochir. Suppl. · Jan 2010
Randomized Controlled TrialEffects of magnesium sulfate infusion on cerebral perfusion in patients after aneurysmal SAH.
A meta-analysis of current data suggests that magnesium sulfate infusion improves the outcome after aneurysmal subarachnoid hemorrhage through a reduction in delayed ischemic neurological deficit. Two multi-center randomized controlled trials are currently underway to investigate this hypothesis. The possible pharmacological basis of this hypothesis includes neuroprotection and vasodilatation. We aim to investigate the cerebral hemodynamic effects of magnesium sulfate infusion in aneurysmal subarachnoid hemorrhage patients. ⋯ Magnesium sulfate infusion, in the dosage of current clinical trials, did not increase cerebral blood volume and cerebral blood flow, as postulated by dilation of small vessels and/or collateral pathways.
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Acta Neurochir. Suppl. · Jan 2010
Randomized Controlled Trial Multicenter StudyIs it possible to minimize overdrainage complications with gravitational units in patients with idiopathic normal pressure hydrocephalus? Protocol of the randomized controlled SVASONA Trial (ISRCTN51046698).
Overdrainage is a common complication observed after shunting patients with idiopathic normal-pressure hydrocephalus (iNPH), with an estimated incidence up to 25%. Gravitational units that counterbalance intracranial pressure changes were developed to overcome this problem. We will set out to investigate whether the combination of a programmable valve and a gravitational unit (proGAV, Aesculap/Miethke, Germany) is capable of reducing the incidence of overdrainage and improving patient-centered outcomes compared to a conventional programmable valve (Medos-Codman, Johnson & Johnson, Germany). ⋯ One planned interim analysis for safety and efficacy will be performed halfway through the study. To detect the hypothesized difference in the incidence of overdrainage with a type I error of 5% and a type II error of 20%, correcting for multiple testing and an anticipated dropout rate of 10%, 200 patients will be enrolled. The presented trial is currently recruiting patients, with the first results predicted to be available in late 2008.