Triamcinolone Levels in Cochlear Perilymph, Lateral Canal and CSF

Phase 1

Completed

• Conditions: Vestibular Schwannoma
• Interventions: Drug: Triamcinolone Acetonide 40mg/mL

• Registration Number: NCT04658836
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-09
• Primary Completion: 2021-08-31
• Study Completion: 2021-10-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triamcinolone application	Triamcinolone Acetonide 40mg/mL	Patients will recieve intratympanic triamcinolone acetonide 24h before vestibular schwannoma surgery

Primary Outcome Measures

Name	Time	Method
Triamcinolone acetonide level	one day	Drug level

Trial Locations

Locations (1)

Medical University of Vienna (AKH); 🇦🇹 Vienna, Austria