Nimodipine in Vestibular Schwanommas

Vestibular Schwannoma Clinical Trial

Official 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 Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04801953
• Other study ID #: 2263/2020
• Status: Recruiting
• Phase: Phase 2
• Start date: May 4, 2021
• Est. completion date: April 9, 2024

Study information

• Verified date: October 2023
• Source: Medical University of Vienna
• Contact: Dorian Hirschmann, Dr
• Phone: +434040025780
• Email: dorian.hirschmann[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 9, 2024
• Est. primary completion date: April 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial nerve function	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	90 days after surgery
Primary	Hearing	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.	90 days after surgery