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72. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC)
Joint Meeting mit der Polnischen Gesellschaft für Neurochirurgie

Deutsche Gesellschaft für Neurochirurgie (DGNC) e. V.

06.06. - 09.06.2021

Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery – study protocol of a randomised multi-centre phase III trial – AkniPro 2

Hörerhalt nach der Operation von Vestibularis Schwannomen durch die prophylaktische Gabe von Nimodipine – Studienprotokoll einer randomisierten, multizentrischen Phase III-Studie „AkniPro 2“

Meeting Abstract

Suche in Medline nach

  • presenting/speaker Christian Scheller - University of Halle-Wittenberg, Neurosurgery, Halle/Saale, Deutschland
  • Christian Strauss - University of Halle-Wittenberg, Neurosurgery, Halle/Saale, Deutschland
  • Torsten Rahne - University of Halle-Wittenberg, Department of Otorhinolaryngology, Head and Neck Surgery, Halle/Saale, Deutschland
  • Andreas Wienke - University of Halle-Wittenberg, Department of Otorhinolaryngology, Head and Neck Surgery, Halle/Saale, Deutschland; University of Halle-Wittenberg, Halle/Saale, Deutschland

Deutsche Gesellschaft für Neurochirurgie. 72. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), Joint Meeting mit der Polnischen Gesellschaft für Neurochirurgie. sine loco [digital], 06.-09.06.2021. Düsseldorf: German Medical Science GMS Publishing House; 2021. DocV185

doi: 10.3205/21dgnc180, urn:nbn:de:0183-21dgnc1807

Veröffentlicht: 4. Juni 2021

© 2021 Scheller et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.


Gliederung

Text

Objective: A previously performed phase III trial on 112 subjects investigating prophylactic nimodipine treatment in vestibular schwannoma (VS) surgery showed no significant effects on preservation of facial and cochlear nerve functions, though it should be considered that protection of facial nerve function was the primary outcome. However, the risk for postoperative hearing loss was halved in the nimodipine group compared to the control group (OR: 0.49; 95%-CI: 0.18-1.30; p=0.15). Accordingly, this phase III extension trial investigates the efficacy and safety of prophylactic nimodipine for hearing preservation in VS surgery.

Methods: This is a randomized, multi-center, prospective, two-armed, open-label phase III trial with blinded expert review and two-stage with interim analysis. 336 adults with the indication for microsurgical removal of VS (Koos I-IV) and serviceable preoperative hearing (Gardner-Robertson scale (GR) 1-3) are assigned to either therapy (intravenous nimodipine 1-2 mg/h from the day before surgery until the fifth postoperative day and standard of care) or control group (surgery only and standard of care). The primary endpoint of the trial is postoperative cochlear nerve function measured before discharge according to GR 1-3 versus GR 4-5 (binary). Hearing function will be determined by pre- and postoperative audiometry with speech discrimination, which will be evaluated by a blinded expert reviewer. Furthermore patient-reported outcomes using standardized questionnaires will be analysed.

Results: Prophylactic parenteral nimodipine treatment may have a positive effect on hearing preservation in VS surgery and would improve patient`s quality of life. Further secondary analysis are planned. Except for dose-depending hypotension nimodipine is known as a safe drug.

Conclusion: In the future, prophylactic nimodipine treatment may be recommended as a routine medication in VS surgery. VS can be considered as an ideal model for clinical evaluation of neuroprotection, since hearing outcome can be classified by well recognized criteria. The beneficial effect of nimodipine may be transferable to other surgical procedures with nerves at risk and may have impact on basic research.

Trial registration: EudraCT-No.: 2019-002317-19, DRKS00019107

Funding: funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation): Project number: 389145064