Analysis of triamcinolone levels in cerebrospinal fluid
Phase 1
- Conditions
- In this study triamcinolone acetonide levels after intratympanic application in the cerebrospinal fluid will be studied. Patients undergoing surgery with dura access will be asked to participate. Patients will receive triamcinolone acetonide applied intratympanically. During surgery a sample of cerebrospinal fluid will be recovered for analysisTherapeutic area: Body processes [G] - Chemical Phenomena [G02]
- Registration Number
- EUCTR2019-001863-60-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
- 60
Inclusion Criteria
Patients between 18 and 90 years, who are willing to participate in the study, will be included Patient who will undergo a surgery with opening of the dura and access to cerebrospinal fluid will be asked to participate in the study.
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
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 Main Objective: Primary Objective<br>Demonstrate presence of Triamcinolone acetonide in cerebrospinal fluid<br>;Secondary Objective: Secondary Objectives<br>•Correlation of timing of application with triamcinolone acetonide levels in cerebrospinal fluid<br>•Assess the relationship of size of cochlear aqueduct (on CT) and triamcinolone level<br>;Primary end point(s): Levels of Triamcinolone acetonide in cerebrospinal fluid;Timepoint(s) of evaluation of this end point: At the end of the study the Triamcinolone acetonide levels will be determined in the cerebrospinal fluid.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): none;Timepoint(s) of evaluation of this end point: not applicable