Nimodipine in Vestibular Schwanommas

NCT ID: NCT04801953

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2024-04-09

Brief Summary

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.

Conditions

Vestibular Schwannoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Nimodipine

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

Group Type: ACTIVE_COMPARATOR

NiMODipine Injectable Solution

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Sodium chloride solution is applied to cranial nerves during surgery

Interventions

NiMODipine Injectable Solution

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

Intervention Type: DRUG

Placebo

Sodium chloride solution is applied to cranial nerves during surgery

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Dorian Hirschmann

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dorian Hirschmann, MD

Role: PRINCIPAL_INVESTIGATOR

University Clinic of Neurosurgery

Karl Roessler, MD

Role: PRINCIPAL_INVESTIGATOR

University Clinic of Neurosurgery

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Dorian Hirschmann, Dr

Role: CONTACT

dorian.hirschmann@meduniwien.ac.at

+434040025780

Facility Contacts

Dorian Hirschmann, MD

Role: primary

dorian.hirschmann@meduniwien.ac.at

+4314040025780

Arthur Hosmann, MD

Role: backup

arthur.hosmann@meduniwien.ac.at

+4314040025780

Other Identifiers

2263/2020

Identifier Type: -

Identifier Source: org_study_id