Analysis of triamcinolone levels in the inner ear liquid
Phase 1
- Conditions
- In this study triamcinolone acetonide levels after intratympanic application in the perilymph, and serum of patients receiving a cochlear implant will be studied. In patients undergoing a translabyrinthine approach to the internal auditory canal with a simultaneous cochlear Implantation additional samples of the perilymphatic fluid at the semiciruclar canal and of cerebrospinal fluid will be taken. Triamcinolone acetonide should have an otoprotective effect.Therapeutic area: Body processes [G] - Chemical Phenomena [G02]
- Registration Number
- EUCTR2017-002377-19-AT
- Lead Sponsor
- Abteilung für Hals-, Nasen- und Ohrenkrankheiten MUW, AKH Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
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 or patients undergoing a translabyrintihne Approach to the internal auditory canal with simultaneous cochlear Implantation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
Patients younger than 18 years .
Patients who receive cortison on a regular level or receive cortison i.v. or p.o. preoperatively .
Patients with contraindications against the administration of Volon? A
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method