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Study on intratympanic steroid therapy on facial nerve decompression surgery

Effect of intratympanic dexamethasone pretreatment on facial neve decompression surgery

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041200042
Enrollment
12
Registered
2020-09-02
Start date
2020-10-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral facial nerve palsy Facial palsy, intratympanic injection, steroid therapy

Interventions

Intratympanic steroid therapy

Sponsors

Inagaki Akira
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 =20 years old who can give consent in writing.

Exclusion criteria

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 =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.

Design outcomes

Primary

MeasureTime frame
Hearing threshold on pure tone audiogram

Secondary

MeasureTime frame
Pitchmatch test, loudness balance test, tinnitus handicap inventory,facial perineurium fluid and serum dexamethasone concentration, residual tympanic perforation

Contacts

Public ContactAkira Inagaki

Nagoya City University Hospital

ainagaki@med.nagoya-cu.ac.jp+81-52-853-8256

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026