Acta neurochirurgica. Supplement
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Acta Neurochir. Suppl. · Jan 2012
Randomized Controlled TrialOn the method of a randomised comparison of programmable valves with and without gravitational units: the SVASONA study.
The supremacy of low-pressure valves (LPV) in the therapy of patients with idiopathic normal pressure hydrocephalus (iNPH) has been proven by the Dutch NPH study. The downside of LPVs is the high rate of overdrainage complications. In the meantime gravitational units have been developed with the objective of minimising overdrainage complications. Do these gravitational units allow the same favourable outcomes as in the Dutch NPH study without overdrainage complications? The goal of this prospective randomised controlled multicentre trial is to compare the rate of overdrainage complications after shunt surgery with programmable valves with or without a gravitational unit. ⋯ The design of the SVASONA study was developed to be able to confirm the primary hypothesis. Thus, the method of the study should solve the dilemma of the Dutch NPH study by the randomised comparison of LPVs with and without gravitational units.
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Acta Neurochir. Suppl. · Jan 2012
Randomized Controlled TrialA microdialysis study of oral vigabatrin administration in head injury patients: preliminary evaluation of multimodality monitoring.
We assessed the feasibility of administering a neuroprotective drug, vigabatrin (VGB; gamma-vinyl-gamma-aminobutyric acid) with multimodality monitoring, including cerebral microdialysis, in severe head injury patients, to measure surrogate endpoints and blood-brain barrier (BBB) penetration. ⋯ Multimodality monitoring, including cerebral microdialysis, is feasible for studying surrogate endpoints following drug administration. VGB crosses the BBB, leading to modest increases in extracellular GABA. Further analyses are ongoing. Microdialysis may assist the development of neuroprotective agents by determining penetration into extracellular fluid of the brain.
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Acta Neurochir. Suppl. · Jan 2011
Review Randomized Controlled TrialIntravenous magnesium sulfate after aneurysmal subarachnoid hemorrhage: current status.
Delayed ischemic neurological deficit or clinical vasospasm remained a major cause for delayed neurological morbidity and mortality for patients with aneurysmal subarachnoid hemorrhage (SAH). Magnesium is a cerebral vasodilator. In experimental model of drug or SAH-induced vasospasm, magnesium blocks voltage-dependent calcium channels and reverses cerebral vasoconstriction. ⋯ Using random effects model (Mantel-Haenszel, Robins-Breslow-Greenland), the pooled odds ratio for symptomatic vasospasm or delayed cerebral ischemia is, 0.620, 95% CI 0.389-0.987, statistically significant. Similarly, the pooled odds ratio for favorable outcome is 1.598, 95% CI 1.074-2.377, statistically significant. There are two multi-center phase III studies (IMASH and MASH2) being carried out to assess the clinical effects, in which IMASH has finished data collection on 30th June 2009.
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Acta Neurochir. Suppl. · Jan 2011
Randomized Controlled Trial Multicenter StudyClazosentan: prevention of cerebral vasospasm and the potential to overcome infarction.
Cerebral vasospasm is a common complication occurring after aneurysmal subarachnoid hemorrhage (SAH). It is recognized as a leading preventable cause of morbidity and mortality in this patient group, but its management is challenging, and new treatments are needed. Clazosentan is an endothelin receptor antagonist designed to prevent endothelin-mediated cerebral vasospasm. ⋯ Clazosentan reduced angiographic vasospasm dose-dependently relative to placebo with a maximum risk reduction of 65% with the highest dose. Despite this, there was no benefit of clazosentan on the secondary protocol-defined morbidity/mortality endpoint; however, additional post-hoc and modified endpoint analyses provided some evidence for a potential clinical benefit. Two additional large-scale studies (CONSCIOUS-2 and CONSCIOUS-3) are now underway to further investigate the potential of clazosentan to improve long-term clinical outcome.
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Acta Neurochir. Suppl. · Jan 2011
Randomized Controlled TrialLong term intrathecal infusion of opiates for treatment of failed back surgery syndrome.
Failed Back Surgery Syndrome (FBSS) is a multidimensional painful condition and its treatment remains a challenge for the surgeons. Prolonged intrathecal infusion of opiates for treatment of noncancer pain also remains a controversial issue. The authors present a prospective study about the long-term treatment of 30 patients with nonmalignant pain treated with intrathecal infusion of morphine from February, 1996 to May, 2004. ⋯ There was improvement of the quality of life measured by SF-36 (30.8-49.6) and in all dimensions of the Treatment of Pain Survey, except for working capacity. The follow-up period ranged from 18 to 98 months (mean = 46.7 months). It was concluded that intrathecal infusion of morphine is a useful and safe tool for long-term treatment of chronic nonmalignant pain.