- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04801953
Nimodipine in Vestibular Schwanommas
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Dorian Hirschmann, Dr
- Phone Number: +434040025780
- Email: dorian.hirschmann@meduniwien.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Medical University of Vienna
-
Contact:
- Dorian Hirschmann, MD
- Phone Number: +4314040025780
- Email: dorian.hirschmann@meduniwien.ac.at
-
Contact:
- Arthur Hosmann, MD
- Phone Number: +4314040025780
- Email: arthur.hosmann@meduniwien.ac.at
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Dorian Hirschmann, MD, University Clinic of Neurosurgery
- Principal Investigator: Karl Roessler, MD, University Clinic of Neurosurgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Otorhinolaryngologic Neoplasms
- Otorhinolaryngologic Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Ear Diseases
- Nervous System Neoplasms
- Cranial Nerve Diseases
- Neuroendocrine Tumors
- Nerve Sheath Neoplasms
- Peripheral Nervous System Neoplasms
- Cranial Nerve Neoplasms
- Neuroma
- Vestibulocochlear Nerve Diseases
- Retrocochlear Diseases
- Neurilemmoma
- Neuroma, Acoustic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Nimodipine
Other Study ID Numbers
- 2263/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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