A Phase 1 interventional study of Triamcinolone Acetonide 40mg/mL in Vestibular Schwannoma, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-08-24.
Sponsored by Medical University of Vienna · Phase 1, Interventional, and Treatment
Patients undergoing surgery of a vestibular schwannoma will be included in the study. Patients will receive triamcinolone acetonide 24h before surgery. During translabyrinthine surgery cochlear perilymph, perilymph from the semicircular canal and cerebrospinal fluid will be taken and analyzed for triamcinolone content. In patients undergoing middle fossa or retrosigmoid resection only cerebrospinal fluid will be taken and analyzed for triamcinolone acetonide level.
Patients between 18 and 90 years undergoing surgery of a vestibular schwannoma will be included in the study. Patients will be offered an application of triamcinolone acetonide intratympanically on the day before surgery.
During surgery samples will be taken to define how much triamcinolone acetonide enters into the perilymphatic fluid, the perilymph of the semicircular canals and CSF.
Patients undergoing translabyrinthine surgery will undergoing labyrinthectomy during which samples of the semicircular canal can be taken. During translabyrinthine surgery nerve monitoring will be carried out using an intracochlear electrode. Before inserting the electrode perilymph of the cochlea can be taken. Immediately after opening the dura cerebrospinal fluid will be taken. Patients undergoing middle fossa or retrosigmoid resection of the vestibular schwannoma will not undergo sampling of the perilymph. In these patients cerebrospinal fluid will be taken to determine triamcinolone acetonide levels.
82 studies on the registry are indexed under Neurilemmoma; 21 are open to participants now.
This study's enrollment of 21 is close to the median of 21 across 47 interventional studies indexed under Neurilemmoma.
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Exclusion Criteria:
Patients will recieve intratympanic triamcinolone acetonide 24h before vestibular schwannoma surgery
Drug: Triamcinolone Acetonide 40mg/mL
Intratympanic application of triamcinolone acetonide
Triamcinolone acetonide level
Drug level
Time frame: one day
Plan to share: No
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna