jRCTs041200042CompletedNot Applicable
Effect of intratympanic dexamethasone pretreatment on facial neve decompression surgery
Not provided0 sites12 target enrollmentStarted: October 20, 2020Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 20age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •1.Diagnosis as peripheral facial nerve palsy at Department of Otolaryngology-Head and Neck, Nagoya City University Hospital.
- •2.Diagnosis as a severe facial palsy of <=8 points of Yanagihara scoring system.
- •3.<=10% Electroneurography value.
- •4.Candidate of facial nerve decompression
- •5.>=20 years old who can give consent in writing.
Exclusion Criteria
- •1.Presence of nonviral inflammation in the middle ear
- •2.Presence of bacterial disease at carriage state.
- •3.Presence of middle ear or inner ear anomaly that would make injection into middle ear impossible.
- •4.Glycated hemoglobin >=6.5%.
- •5.Creatinine clearance <=50 ml/min
- •6.Alanine transaminase >=100 U/l or aspartate transaminase >=100 U/l.
- •7.Severely protracted wound healing.
- •8.Signs of central facial palsy or other neurological disease that could potentially affect facial function
- •9.Pregnancy or possible pregnancy
- •10.Participation in other clinical trials within 3 months
- •11.History of dexamethasone treatment within 2 weeks
- •12.Recurrent facial palsy
- •13.Unable to properly conduct pure tone audiometry test, pitch match test, roundness balance test or tinnitus handicap inventory test.
- •14.Inappropriate for participation in the trial in the opinion of the investigators.
Outcomes
Primary Outcomes
-
Hearing threshold on pure tone audiogram
Secondary Outcomes
No secondary outcomes reported
Investigators
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