Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery: study protocol of a randomized multi-center phase III trial-AkniPro 2.

ABSTRACT:

Background

A previously performed phase III trial on 112 subjects investigating prophylactic nimodipine treatment in vestibular schwannoma (VS) surgery showed no clear beneficial 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, two-armed, open-label phase III trial with blinded expert review and two-stage with interim analysis

SUBMITTER: Scheller C 

PROVIDER: S-EPMC8296656 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature