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Triamcinolone Levels in Cochlear Perilymph, Lateral Canal and CSF

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ClinicalTrials.gov Identifier: NCT04658836
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Christoph Arnoldner, Medical University of Vienna

Study Description
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Brief Summary:
Patients undergoing surgery of a vestibular schwannoma will be included in the study. Patients will receive triamcinolone acetonide 24h before surgery. During translabyrinthine surgery cochlear perilymph, perilymph from the semicircular canal and cerebrospinal fluid will be taken and analyzed for triamcinolone content. In patients undergoing middle fossa or retrosigmoid resection only cerebrospinal fluid will be taken and analyzed for triamcinolone acetonide level.

Condition or disease Intervention/treatment Phase
Vestibular Schwannoma Drug: Triamcinolone Acetonide 40mg/mL Phase 1

Detailed Description:

Patients between 18 and 90 years undergoing surgery of a vestibular schwannoma will be included in the study. Patients will be offered an application of triamcinolone acetonide intratympanically on the day before surgery.

During surgery samples will be taken to define how much triamcinolone acetonide enters into the perilymphatic fluid, the perilymph of the semicircular canals and CSF.

Patients undergoing translabyrinthine surgery will undergoing labyrinthectomy during which samples of the semicircular canal can be taken. During translabyrinthine surgery nerve monitoring will be carried out using an intracochlear electrode. Before inserting the electrode perilymph of the cochlea can be taken. Immediately after opening the dura cerebrospinal fluid will be taken. Patients undergoing middle fossa or retrosigmoid resection of the vestibular schwannoma will not undergo sampling of the perilymph. In these patients cerebrospinal fluid will be taken to determine triamcinolone acetonide levels.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Triamcinolone Acetonide Levels in Cochlear Perilymph, Lateral Canal and CSF in Patients With Vestibular Schwannomas
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acoustic Neuroma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Triamcinolone application
Patients will recieve intratympanic triamcinolone acetonide 24h before vestibular schwannoma surgery
 Drug: Triamcinolone Acetonide 40mg/mL
Intratympanic application of triamcinolone acetonide


Outcome Measures
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Primary Outcome Measures :
  1. Triamcinolone acetonide level [ Time Frame: one day ]
    Drug level


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between 18 and 90 years undergoing a surgery of the cerebellopontine angle due to vestibular schwannoma and who are willing to participate in the study

Exclusion Criteria:

  • Patients younger than 18 years Patients who receive cortison regularly or receive cortison i.v. or p.o. preoperatively Patients with contraindications against the administration of VolonâA
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658836


Contacts
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Contact: Valerie Dahm, MD +43/1/40400/33300 valerie.dahm@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna (AKH) Recruiting
Vienna, Austria, 1090
Contact: Valerie Dahm, MD    0043/1/40400 ext 33300    valerie.dahm@meduniwien.ac.at   
Principal Investigator: Christoph Arnoldner, Prof.         
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Christoph Arnoldner Medical University of Vienna, Otorhinolaryngology, Head and Neck Surgery
More Information
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Responsible Party: Christoph Arnoldner, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04658836    
Other Study ID Numbers: TACCSF
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurilemmoma
Neuroma, Acoustic
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
 Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Nervous System Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs