Nimodipine in Vestibular Schwanommas

Phase 2

Recruiting

• Conditions: Vestibular Schwannoma
• Interventions: Other: Placebo; Drug: NiMODipine Injectable Solution

• Registration Number: NCT04801953
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-13
• Study First Submitted QC: 2021-03-13
• Study First Posted: 2021-03-17
• Study Start: 2021-05-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Primary Completion: 2024-04-09
• Study Completion: 2024-04-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age > 18a
• Vestibular schwannoma with maximum diameter of 10-25mm on MRI
• Pre-operative audiogram
• Informed consent

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Exclusion Criteria

• Contraindication for nimodipine application
• Vestibularis schwannoma diameter <10mm or >25mm on MRI

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	During surgery a sodium chloride soaked gel foam pad is administered to the cranial nerves VII and VIII
Nimodipine	NiMODipine Injectable Solution	During surgery a nimodipine soaked gel foam pad is administered to the cranial nerves VII and VIII

Primary Outcome Measures

Name	Time	Method
Facial nerve function	90 days after surgery	Function of the facial nerve according to House-Brackmann score. The House Brackmann score includes values from 1 to 6: 1 = normal function, 2 = minimal paresis, 3 = noticable paresis, 4 = severe paresis, 5 = minimum fuction, 6 = complete paralysis
Hearing	90 days after surgery	Serviceable or non-serviceable hearing according to Gardner-Robertson scale. The Gardner-Robertson scale indludes values from 1 to 5: 1 and 2 indicating serviceable hearing, 3-5 indicating non-serviceable hearing. The scores from 1 to 5 differ in values of pure tone audiometry and speech discrimination, 1 indicates best function and 5 worst function.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria