Application of nimodipine to the cranial nerves during vestibular schwannoma resection to avoid post-operative facial weakness and deafness
Phase 1
- Conditions
- Patients with vestibularis schwanomma undergoing microsurgical resectionTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-005215-46-AT
- Lead Sponsor
- Department of Neurosurgery, Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
patient age > 18 years
vestibularis schwannoma with a maximum diameter of 10-25mm on MRI
pre-operative audiogram
informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
contraindication for nimodipine application
vestibularis schwannoma diameter <10mm or >25mm on MRI
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: We propose to investigate, if intra-operative local nimodipine application after vestibularis schwannoma resection can improve cochlea and facial function at 3 months after surgery compared to placebo<br>;Secondary Objective: We propose to investigate, if intra-operative local nimodipine application after vestibularis schwannoma resection can improve intra-operative blood flow of the cochlea and facial nerves<br>;Primary end point(s): Gardner-Robertson Scale<br>House–Brackmann score<br>;Timepoint(s) of evaluation of this end point: 5±2 days and 90±10 days after surgery
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Perfusion of cochlea and facial nerve;Timepoint(s) of evaluation of this end point: at surgery (before and after nimodipine/placebo application)