Triamcinolone Levels in Cochlear Perilymph, Lateral Canal and CSF

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT04658836

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

Actual Enrollment :

21 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 :

Feb 1, 2020

Actual Primary Completion Date :

Aug 31, 2021

Actual Study Completion Date :

Oct 31, 2021

Arms and Interventions

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

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

Primary Outcome Measures

Triamcinolone acetonide level [one day]
Drug level

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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