Effect of intratympanic dexamethasone pretreatment on facial neve decompression surgery

未提供0 个研究点目标入组 12 人开始时间: 2020年10月20日最近更新: 2023年10月1日

试验速览

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•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.

•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.

Hearing threshold on pure tone audiogram

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发起方

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