Nimodipine in Vestibular Schwanommas

Study Purpose

Title: 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.

Background: In patients undergoing microsurgical resection of a vestibular schwannoma, the facial and vestibulocochlear nerves are at risk. Prior studies suggested positive effects of nimodipine for preservation of the nerve function in these patients. A prospective, randomized, placebo controlled double-blinded study will be conducted to evaluate the neuro-protective effect of locally administered nimodipine during resection of vestibular schwannomas. Investigational drug: active group: "Nimotop® 10mg

- Infusionsflasche" placebo: "Natrium chloratum physiologicum 0,9% - Medica Infusionslösung" Rationale for the study: Nimodipine is supposed to counteract the vasoconstriction of cerebral arteries caused by microsurgical manipulation and might thereby preserve facial and cochlear nerve function.

Aims of the study: Evaluation of the effect of intraoperative local administration of nimodipine on the postoperative function of the facial and vestibulocochlear nerves after microsurgical resection of vestibular schwannomas. Study design: prospective, double-blinded, single-center, randomized phase III trial. Study population: Patients undergoing microsurgical resection of a vestibularis schwannoma with a maximum diameter of 10-25mm on MRI at the Department of Neurosurgery, Medical university of Vienna. Number of Patients: 30. Methods: In 15 patients, nimodipine will be administered locally to the facial and vestibulocochlear nerves during resection of a vestibular schwannoma (= treatment group). In another 15 patients, a placebo (sodium chloride solution) will be administered. In both cases, a soaked gel foam pad will be used. The operating team and the patient will both be blinded during the procedure. Facial nerve function and hearing will be assessed prior and three months after surgery. Outcome variables: Serviceable or non-serviceable hearing according to Gardner-Robertson hearing scale and House-Brackmann score for the assessment of facial nerve function. Statistical analysis: For the evaluation of the postoperative function of the vestibulocochlear nerve, the number of patients with postoperative serviceable hearing (Gardner-Robertson I-II) and postoperative non-serviceable hearing (Gardner-Robertson III-V) will be compared between both groups. For the evaluation of the facial nerve function, the number of patients with favorable postoperative outcome (House-Brackmann I-III) and non-favorable postoperative outcome (House-Brackmann IV-VI) will be compared. In both cases, fisher's exact test will be used. Expected risks/inconveniences: Administration of nimodipine is associated with the following adverse effects: thrombocytopenia, allergic reactions, headache, tachycardia, hypotension, nausea (occasionally) and bradycardia, ileus, reversibly elevated liver enzymes (seldom) Risk/benefit assessment: Expected adverse effects of local nimodipine administration are manageable and patients may profit from the use of nimodipine. No severe adverse events are expected.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age > 18a.

- Vestibular schwannoma with maximum diameter of 10-25mm on MRI.

- Pre-operative audiogram.

- Informed consent.

Exclusion Criteria:

- Contraindication for nimodipine application.

- Vestibularis schwannoma diameter <10mm or >25mm on MRI

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04801953
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Medical University of Vienna
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Dorian Hirschmann, MDKarl Roessler, MD
Principal Investigator Affiliation	University Clinic of NeurosurgeryUniversity Clinic of Neurosurgery
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Austria
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Vestibular Schwannoma

Arms & Interventions

Arms

Active Comparator: Nimodipine

During surgery a nimodipine soaked gel foam pad is administered to the cranial nerves VII and VIII

Placebo Comparator: Placebo

During surgery a sodium chloride soaked gel foam pad is administered to the cranial nerves VII and VIII

Interventions

Drug: - NiMODipine Injectable Solution

nimodipine solution is applied to cranial nerves during resection of vestibular schwannoma

Other: - Placebo

Sodium chloride solution is applied to cranial nerves during surgery

Contact a Trial Team

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International Sites

Medical University of Vienna, Vienna, Austria

Status

Recruiting

Address

Medical University of Vienna

Vienna, , 1090

Site Contact

Dorian Hirschmann, MD

[email protected]

+4314040025780

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