Triamcinolone Levels in Cochlear Perilymph

Christoph Arnoldner

Status and phase: Completed; Phase 1

Conditions: Cochlear Hearing Loss

Treatments: Drug: Triamcinolone Acetonide

Study type: Interventional

Funder types: Other

Identifiers

NCT03248856

1456/2017

2017-002377-19 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Group 1

Other group

Description:

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

Treatment:

Drug: Triamcinolone Acetonide

Group 2

Other group

Description:

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

Treatment:

Drug: Triamcinolone Acetonide

Group 3

Other group

Description:

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

Treatment:

Drug: Triamcinolone Acetonide

Group 4

Other group

Description:

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

Treatment:

Drug: Triamcinolone Acetonide