Triamcinolone Levels in Cochlear Perilymph

Study Overview
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Brief Summary
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In this study Triamcinolone acetonide will be applied intratympanically before cochlear implant surgery. After round window exposure, a perilymph sample and simultaneously a blood sample will be drawn. Triamcinolone levels will then be analyzed in the samples.

Detailed Description
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At the ENT department of the university hospital Vienna (AKH Wien) patients are treated with intratympanic triamcinolone acetonide before cochlea implantation to reduce inflammation and in some cases to protect residual hearing. Triamcinolone acetonide levels in cochlear perilymph will be evaluated in an open prospective clinical study. Patients scheduled for cochlear implant surgery between 18 and 90 years will be included. Patients who are treated with steroids preoperatively will be excluded from the study. Patients will be randomized after inclusion to one of four groups. The randomization is carried out to generate hypothesis for the needed dose and best time of application in the future. Triamcinolone acetonide will then be applied 20-24h before surgery or at the beginning of the surgery, depending on randomization (see below). About 20 µl of perilymph will be sampled simultaneously to a blood sample during cochlear implant surgery. The probes will be stored at -80°C. Triamcinolone acetonide levels of the blood and perilymph will be determined by the pharmaceutical laboratory (Department of Pharmaceutical Technology and Biopharmaceutics, University of Vienna). The patients will be randomized to 4 groups. Group 1 - Volon A 10mg administration 20 - 24 hours before sampling. Group 2 - Volon A 40mg administration 20 - 24 hours before sampling. Group 3 Volon A 10mg - administration 1 to 2 hours before sampling. Group 4 - Volon A 40mg administration 1 to 2 hours before sampling. The time interval of application (1 to 2 hours and 20 to 24 hours before sampling) are a result of varying time of surgery depending on surgeons and patient anatomy as well as day to day clinical organization. Patients can withdraw consent at any time of the study. The active phase of each patient will be between 6 and 9 days depending on time of follow-up visit.

Official Title
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Triamcinolone Levels in Cochlear Perilymph

Conditions
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Cochlear Hearing Loss

Intervention / Treatment
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* Drug: Triamcinolone Acetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18 and 90 years will be included in the study, who will undergo a cochlear implantation and are willing to participate in the study Exclusion Criteria: Patients younger than 18 years Patients who receive cortisone on a regular basis or receive cortisone i.v. or p.o. preoperatively Patients with contraindications against the administration of Volon A

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Group 1 will receive triamcinolone acetonide 10mg 20 to 24hours before sampling. | Drug: Triamcinolone Acetonide<br>* Intratympanic administration<br>|
| Other: Group 2<br>Group 2 will receive triamcinolone acetonide 40mg 20 to 24hours before sampling. | Drug: Triamcinolone Acetonide<br>* Intratympanic administration<br>|
| Other: Group 3<br>Group 3 will receive triamcinolone acetonide 10mg 1 to 2 hours before sampling. | Drug: Triamcinolone Acetonide<br>* Intratympanic administration<br>|
| Other: Group 4<br>Group 3 will receive triamcinolone acetonide 40mg 1 to 2 hours before sampling. | Drug: Triamcinolone Acetonide<br>* Intratympanic administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triamcinolone levels in comparison | Absorption of Triamcinolone acetonide in cochlear perilymph in comparison to dissemination to the blood circulation | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triamcinolone stability | The stability of triamcinolone acetonide levels in the cochlear perilymph | 2 years | 
| Triamcinolone concentrations | Perilymph concentrations and blood concentrations of triamcinolone acetonide after administration of different Triamcinolone acetonide doses. | 2 years | 
| Impedances | Difference of impedances of patients receiving different doses at different timepoints | 2 years |