Triamcinolone Levels in Cochlear Perilymph
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Triamcinolone levels in comparison
研究概览
简要总结
In this study Triamcinolone acetonide will be applied intratympanically before cochlear implant surgery. After round window exposure, a perilymph sample and simultaneously a blood sample will be drawn. Triamcinolone levels will then be analyzed in the samples.
详细描述
At the ENT department of the university hospital Vienna (AKH Wien) patients are treated with intratympanic triamcinolone acetonide before cochlea implantation to reduce inflammation and in some cases to protect residual hearing. Triamcinolone acetonide levels in cochlear perilymph will be evaluated in an open prospective clinical study. Patients scheduled for cochlear implant surgery between 18 and 90 years will be included. Patients who are treated with steroids preoperatively will be excluded from the study. Patients will be randomized after inclusion to one of four groups. The randomization is carried out to generate hypothesis for the needed dose and best time of application in the future. Triamcinolone acetonide will then be applied 20-24h before surgery or at the beginning of the surgery, depending on randomization (see below). About 20 µl of perilymph will be sampled simultaneously to a blood sample during cochlear implant surgery.
The probes will be stored at -80°C. Triamcinolone acetonide levels of the blood and perilymph will be determined by the pharmaceutical laboratory (Department of Pharmaceutical Technology and Biopharmaceutics, University of Vienna).
The patients will be randomized to 4 groups. Group 1 - Volon A 10mg administration 20 - 24 hours before sampling. Group 2 - Volon A 40mg administration 20 - 24 hours before sampling. Group 3 Volon A 10mg - administration 1 to 2 hours before sampling. Group 4 - Volon A 40mg administration 1 to 2 hours before sampling.
The time interval of application (1 to 2 hours and 20 to 24 hours before sampling) are a result of varying time of surgery depending on surgeons and patient anatomy as well as day to day clinical organization. Patients can withdraw consent at any time of the study.
The active phase of each patient will be between 6 and 9 days depending on time of follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 90 years will be included in the study, who will undergo a cochlear implantation and are willing to participate in the study
排除标准
- •Patients younger than 18 years
- •Patients who receive cortisone on a regular basis or receive cortisone i.v. or p.o. preoperatively
- •Patients with contraindications against the administration of Volon A
研究组 & 干预措施
Group 1
Group 1 will receive triamcinolone acetonide 10mg 20 to 24hours before sampling.
干预措施: Triamcinolone Acetonide (Drug)
Group 2
Group 2 will receive triamcinolone acetonide 40mg 20 to 24hours before sampling.
干预措施: Triamcinolone Acetonide (Drug)
Group 3
Group 3 will receive triamcinolone acetonide 10mg 1 to 2 hours before sampling.
干预措施: Triamcinolone Acetonide (Drug)
Group 4
Group 3 will receive triamcinolone acetonide 40mg 1 to 2 hours before sampling.
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Triamcinolone levels in comparison
时间窗: 2 years
Absorption of Triamcinolone acetonide in cochlear perilymph in comparison to dissemination to the blood circulation
次要结局
- Triamcinolone stability(2 years)
- Impedances(2 years)
- Triamcinolone concentrations(2 years)
研究者
Christoph Arnoldner
Assoc Prof PD Dr.
Medical University of Vienna