Back to results

Triamcinolone Levels in Cochlear Perilymph, Lateral Canal and CSF

Primary Purpose

Vestibular Schwannoma

Status

Completed

Phase

Phase 1

Locations

Austria

Study Type

Interventional

Intervention

Triamcinolone Acetonide 40mg/mL

About this trial

This is an interventional treatment trial for Vestibular Schwannoma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University of Vienna (AKH)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triamcinolone application

Arm Description

Patients will recieve intratympanic triamcinolone acetonide 24h before vestibular schwannoma surgery

Outcomes

Primary Outcome Measures

Triamcinolone acetonide level

Drug level

Secondary Outcome Measures

Full Information

NCT ID

NCT04658836

First Posted

June 23, 2020

Last Updated

August 22, 2022

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT04658836

Brief Title

Triamcinolone Levels in Cochlear Perilymph, Lateral Canal and CSF

Official Title

Triamcinolone Acetonide Levels in Cochlear Perilymph, Lateral Canal and CSF in Patients With Vestibular Schwannomas

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

February 1, 2020 (Actual)

Primary Completion Date

August 31, 2021 (Actual)

Study Completion Date

October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vestibular Schwannoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Triamcinolone application

Arm Type

Experimental

Arm Description

Patients will recieve intratympanic triamcinolone acetonide 24h before vestibular schwannoma surgery

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide 40mg/mL

Intervention Description

Intratympanic application of triamcinolone acetonide

Primary Outcome Measure Information:

Title

Triamcinolone acetonide level

Description

Drug level

Time Frame

one day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Arnoldner

Organizational Affiliation

Medical University of Vienna, Otorhinolaryngology, Head and Neck Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Vienna (AKH)

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Triamcinolone Levels in Cochlear Perilymph, Lateral Canal and CSF

We'll reach out to this number within 24 hrs