Triamcinolone Levels in Cochlear Perilymph

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-02

Study Completion Date

2021-05-31

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.

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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.

Conditions

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Cochlear Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1

Group 1 will receive triamcinolone acetonide 10mg 20 to 24hours before sampling.

Group Type OTHER

Triamcinolone Acetonide

Intervention Type DRUG

Intratympanic administration

Group 2

Group 2 will receive triamcinolone acetonide 40mg 20 to 24hours before sampling.

Group Type OTHER

Triamcinolone Acetonide

Intervention Type DRUG

Intratympanic administration

Group 3

Group 3 will receive triamcinolone acetonide 10mg 1 to 2 hours before sampling.

Group Type OTHER

Triamcinolone Acetonide

Intervention Type DRUG

Intratympanic administration

Group 4

Group 3 will receive triamcinolone acetonide 40mg 1 to 2 hours before sampling.

Group Type OTHER

Triamcinolone Acetonide

Intervention Type DRUG

Intratympanic administration

Interventions

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Triamcinolone Acetonide

Intratympanic administration

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No