Prophylactic nimodipine treatment and improvement in hearing outcome after vestibular schwannoma surgery: a combined analysis of a randomized, multicenter, Phase III trial and its pilot study

Scheller C, Wienke A, Tatagiba M, Gharabaghi A, Ramina KF, Ganslandt OT, Bischoff B, Zenk J, Engelhorn T, Matthies C, Westermaier T, Antoniadis G, Pedro MT, Rohde V, Von Eckardstein K, Kretschmer T, Kornhuber M, Steighardt J, Richter M, Barker FG, Strauss C (2017)

Publication Type: Journal article

Publication year: 2017

Journal

Journal of Neurosurgery American Association of Neurological Surgeons

Book Volume: 127

Pages Range: 1376-1383

Journal Issue: 6

DOI: 10.3171/2016.8.JNS16626

Abstract

OBJECTIVE In clinical routines, neuroprotective strategies in neurosurgical interventions are still missing. A pilot study (n = 30) and an analogously performed Phase III trial (n = 112) pointed to a beneficial effect of prophylactic nimodipine and hydroxyethyl starch (HES) in vestibular schwannoma (VS) surgery. Considering the small sample size, the data from both studies were pooled. METHODS The patients in both investigator-initiated studies were assigned to 2 groups. The treatment group (n = 70) received parenteral nimodipine (1-2 mg/hour) and HES (hematocrit 30%-35%) from the day before surgery until the 7th postoperative day. The control group (n = 72) was not treated prophylactically. Facial and cochlear nerve functions were documented preoperatively, during the inpatient care, and 1 year after surgery. RESULTS Pooled raw data were analyzed retrospectively. Intent-to-treat analysis revealed a significantly lower risk for hearing loss (Class D) 12 months after surgery in the treatment group compared with the control group (OR 0.46, 95% CI 0.22-0.97; p = 0.04). After exclusion of patients with preoperative Class D hearing, this effect was more pronounced (OR 0.38, 95% CI 0.17-0.83; p = 0.016). Logistic regression analysis adjusted for tumor size showed a 4 times lower risk for hearing loss in the treatment group compared with the control group (OR 0.25, 95% CI 0.09-0.63; p = 0.003). Facial nerve function was not significantly improved with treatment. Apart from dose-dependent hypotension (p < 0.001), the study medication was well tolerated. CONCLUSIONS Prophylactic nimodipine is safe and may be recommended in VS surgery to preserve hearing. Prophylactic neuroprotective treatment in surgeries in which nerves are at risk seems to be a novel and promising concept. Clinical trial registration no.: DRKS 00000328 ( https://drks-neu.uniklinik-freiburg.de/drks_web/ ).

Authors with CRIS profile

Oliver Thomas Ganslandt Medizinische Fakultät Tobias Martin Engelhorn Department of Neuroradiology

Additional Organisation(s)

Department of Otorhinolaryngology – Head and Neck Surgery

Involved external institutions

Martin-Luther-Universität Halle-Wittenberg (MLU) DE Germany (DE) Carl von Ossietzky Universität Oldenburg DE Germany (DE) Eberhard Karls Universität Tübingen DE Germany (DE) Universität Ulm DE Germany (DE) Georg-August-Universität Göttingen DE Germany (DE) Universitätsklinikum Würzburg DE Germany (DE) Massachusetts General Hospital US United States (USA) (US)

How to cite

APA:

Scheller, C., Wienke, A., Tatagiba, M., Gharabaghi, A., Ramina, K.F., Ganslandt, O.T.,... Strauss, C. (2017). Prophylactic nimodipine treatment and improvement in hearing outcome after vestibular schwannoma surgery: a combined analysis of a randomized, multicenter, Phase III trial and its pilot study. Journal of Neurosurgery, 127(6), 1376-1383. https://dx.doi.org/10.3171/2016.8.JNS16626

MLA:

Scheller, Christian, et al. "Prophylactic nimodipine treatment and improvement in hearing outcome after vestibular schwannoma surgery: a combined analysis of a randomized, multicenter, Phase III trial and its pilot study." Journal of Neurosurgery 127.6 (2017): 1376-1383.

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