Artikel
Prophylactic nimodipine treatment for cochlear and facial nerve preservation after vestibular schwannoma surgery: a randomised multi-center phase III trial
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Autoren
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Christian Scheller
- Department of Neurosurgery, University of Halle-Wittenberg, Germany; Translational Centre for Regenerative Medicine (TRM), University of Leipzig, Germany
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Andreas Wienke
- Institute of Medical Epidemiology, Biostatistics, and Informatics, University of Halle-Wittenberg, Germany
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Marcos Tatagiba
- Department of Neurosurgery, University of Tübingen, Germany
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Alireza Gharabaghi
- Department of Neurosurgery, University of Tübingen, Germany
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Kristofer F. Ramina
- Department of Neurosurgery, University of Tübingen, Germany
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Oliver Ganslandt
- Department of Neurosurgery, University of Erlangen-Nuremberg, Germany
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Barbara Bischoff
- Department of Neurosurgery, University of Erlangen-Nuremberg, Germany
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Cordula Matthies
- Department of Neurosurgery, Würzburg University Hospital, Germany
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Thomas Westermaier
- Department of Neurosurgery, Würzburg University Hospital, Germany
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Gregor Antoniadis
- Department of Neurosurgery, Bezirkskrankenhaus Günzburg, University of Ulm, Germany
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Maria Teresa Pedro
- Department of Neurosurgery, Bezirkskrankenhaus Günzburg, University of Ulm, Germany
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Veit Rohde
- Department of Neurosurgery, University of Göttingen, Germany
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Kajetan von Eckardstein
- Department of Neurosurgery, University of Göttingen, Germany
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Thomas Kretschmer
- Department of Neurosurgery, Evangelisches Krankenhaus, University of Oldenburg, Germany
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Christian Strauss
- Department of Neurosurgery, University of Halle-Wittenberg, Germany
| Veröffentlicht: | 2. Juni 2015 |
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Gliederung
Text
Objective: A pilot-study of prophylactic nimodipine and hydroxyethylstarch treatment showed a beneficial effect on facial and cochlear nerve preservation following vestibular schwannoma surgery. A prospective phase III trial was undertaken to confirm these results.
Method: An open-label, two-armed, randomised parallel-group and multi-center phase III trial with blinded expert review was performed between January 2010 and February 2013 at seven Departments of Neurosurgery in order to investigate the efficacy and safety of the prophylaxis in 112 patients with vestibular schwannoma surgery, which were randomly assigned to two groups using online randomization. Function of the facial nerve twelve months after surgery was assessed as the primary outcome. Secondary outcomes were cochlear nerve function twelve months after surgery and adverse events. The therapy group (n=56) received parenteral nimodipine (1-2 mg/h) and hydroxyethylstarch (hematocrit: 30-35%) from the day before surgery until the seventh postoperative day. The control group (n=56) was not treated prophylactically.
Results: Intent-to treat analysis showed no statistical significant effects of the treatment on both facial (p=0.745) and hearing preservation (p=0.530) twelve months after surgery. However, tumor sizes were significantly larger in the therapy versus control groups. Logistic regression analysis was required and revealed a two times higher chance of hearing preservation (OR: 2.00; 95%-CI: 0.76-5.26) for all tumor sizes and an almost three times higher chance (OR: 2.90; 95%-CI: 0.76-11.11) in the subgroup with Koos III and IV tumors in the therapy group. The probability of postoperative unimpaired facial nerve function was 34% higher (OR: 1.34; 95%-CI: 0.41-4.40) in the therapy group. Apart from dose-dependent hypotension (p<0.001) no additional clinically relevant adverse reactions were observed.
Conclusions: There were no statistical significant effects of the treatment. Despite the width of the confidence intervals the ORs may suggest but do not prove a clinically relevant effect of the safe study medication on the preservation of both the facial and particular the cochlear nerve functions after vestibular schwannoma surgery. Additional study is mandatory before prophylactic nimodipine may be recommended in vestibular schwannoma surgery.
