Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Electrode Impedance(Ohm)
研究概览
简要总结
The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods.
详细描述
The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods. Participants who will have cochlear implant surgery will be divided into three groups. Group 1 will have intracochlear dexamethasone after the incision of the round window membrane. Group 2 will have intratympanic dexamethasone after the incision of the round window membrane. Group 3 will serve as a control group. All participants will be tested after a week, a month, 3, and 6 months. Impedance and threshold measurements will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with sensorineural hearing loss
- •Patients who will have cochlear implant surgery with CI422 electrode
排除标准
- •Patients with cochlear abnormality
- •Patients with auditory neuropathy
研究组 & 干预措施
Group 1
intracochlear dexamethasone application during cochlear implantation
干预措施: Intracochlear Dexamethasone (Drug)
Group 2
intratympanic dexamethasone application during cochlear implantation
干预措施: Intratympanic Dexamethasone (Drug)
Group 3
No drugs during cochlear implantation
干预措施: No additional drugs(control Group) (Drug)
结局指标
主要结局
Electrode Impedance(Ohm)
时间窗: 1-3 months
All intra-operative impedance values will be acquired after surgery. They will be repeated in first and 3 rd months
Electrode thresholds(CL)
时间窗: 1-3 months
All intra-operative thresholds will be acquired after surgery. They will be repeated in first and 3 rd months
次要结局
未报告次要终点
研究者
Fazıl Necdet Ardıç
Prof.Dr.
Pamukkale University