jRCTs041200042已完成不适用
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:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 No limit(—)
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
-
Hearing threshold on pure tone audiogram
次要结局
未报告次要终点
研究者
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