Nimodipine in Vestibular Schwanommas

October 18, 2023 updated by: Dorian Hirschmann, Medical University of Vienna

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

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.

Study Overview

Status

Recruiting

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dorian Hirschmann, MD
        • Principal Investigator:
          • Karl Roessler, MD
        • Sub-Investigator:
          • Fabian Winter, MD
        • Sub-Investigator:
          • Elisabeth Strasser, MD
        • Sub-Investigator:
          • Arthur Hosmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nimodipine
During surgery a nimodipine soaked gel foam pad is administered to the cranial nerves VII and VIII
nimodipine solution is applied to cranial nerves during resection of vestibular schwannoma
Placebo Comparator: Placebo
During surgery a sodium chloride soaked gel foam pad is administered to the cranial nerves VII and VIII
Sodium chloride solution is applied to cranial nerves during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial nerve function
Time Frame: 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
90 days after surgery
Hearing
Time Frame: 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.
90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dorian Hirschmann, MD, University Clinic of Neurosurgery
  • Principal Investigator: Karl Roessler, MD, University Clinic of Neurosurgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2021

Primary Completion (Estimated)

April 9, 2024

Study Completion (Estimated)

April 9, 2024

Study Registration Dates

First Submitted

March 13, 2021

First Submitted That Met QC Criteria

March 13, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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