Application of nimodipine to the cranial nerves during vestibular schwannoma resection to avoid post-operative facial weakness and deafness

Intraoperative application of nimodipine to the facial and cochlear nerves during vestibular schwannoma resection to avoid spasm-related postoperative facial paralysis and deafness - a prospective randomized study - Nimodipine Vestibularis Schwannoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005215-46-AT

Enrollment

Registered

2020-11-18

Start date

2021-02-19

Completion date

Unknown

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with vestibularis schwanomma undergoing microsurgical resection

Interventions

Trade Name: Nimotop® 10mg – Infusionsflasche Product Name: Nimotop® 10mg – Infusionsflasche Pharmaceutical Form: Infusion INN or Proposed INN: NIMODIPINE CAS Number: 66085-59-4 Concentration unit: mg/

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: contraindication for nimodipine application vestibularis schwannoma diameter 25mm on MRI

Design outcomes

Primary

Measure	Time frame
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 ;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 ;Primary end point(s): Gardner-Robertson Scale House–Brackmann score ;Timepoint(s) of evaluation of this end point: 5±2 days and 90±10 days after surgery	—

Measure

Time frame

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 ;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 ;Primary end point(s): Gardner-Robertson Scale House–Brackmann score ;Timepoint(s) of evaluation of this end point: 5±2 days and 90±10 days after surgery

—

Secondary

Measure	Time frame
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)	—

Countries

Austria

Contacts

Public ContactSecretary

Department of Neurosurgery, Medical University of Vienna

arthur.hosmann@meduniwien.ac.at0043014040025650

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026