Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With no Measurable Remaining Vestibular Function
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Differences and changes of postural control following surgery, compared to before surgery
研究概览
简要总结
The purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating vestibular function prior to surgery, even if vestibular function is absent according to modern assessment techniques
详细描述
Patients subjected to vestibular schwannoma surgery most often suffer from vertigo after surgery, even if no vestibular function can be found in pre-surgical assessment. According to retrospective data about 33% of patients scheduled for surgery do not have any measurable vestibular function. Even the occurrence of spontaneous nystagmus has been recorded in patients with no or very little function prior to surgery (Parietti-Winkler et al. 2008 JNNP). This indicates that despite new methods of measuring vestibular function, remaining vestibular function can be present and patients might benefit from pre-treatment of gentamicin (Tjernström et al. 2009 JNNP)
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vestibular schwannoma advised to surgical treatment
- •No measurable remaining vestibular function
排除标准
- •impaired decision making
- •neurofibromatosis
- •signs for central dysfunction
- •remaining vestibular function
- •Patients are advised not to participate in the gentamicin arm if
- •hearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz) and speech discrimination better than 70%
- •the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin associated hearing loss
研究组 & 干预措施
Gentamicin treated
Installation of gentamicin in the middle ear 6 weeks prior to surgery + rehabilitation exercises before and after both treatment and surgery.
Rehabilitation exercises are not considered to be an intervention since their benign impact on vestibular/postural compensation is well documented and exclusion from exercises would not be approved by the ethical board
干预措施: Gentamicin (Drug)
结局指标
主要结局
Differences and changes of postural control following surgery, compared to before surgery
时间窗: At first vestibular assessment at the time for inclusion and 6 months after surgery
Postural control assessed with posturography during a sensory conflict
次要结局
- Occurrence of spontaneous nystagmus after surgery(Day 1 after surgery and for the duration of either spontaneous nystagmus or hospital stay (up to 2 weeks))
- Differences of duration of hospital stay(After surgery for the duration of the hospital stay up to 2 weeks)
- Change of hearing levels(At first vestibular assessment and 4weeks after gentamicin installation)
- Differences of subjective well being after surgery(Immediate time after surgery (2weeks))
- Change of level of perceived anxiety/depression after surgery as compared to before surgery(At first vestibular assessment (inclusion) and 6 months after surgery)
- Differences in vestibular compensation after surgery(6 months after surgery)
- Differences in the level of stress after surgery(Daily after surgery for the duration of the hospital stay, up to 2 weeks)
- Change of vestibular function after gentamicin treatment(6 weeks after gentamicin treatment)
- Differences of subjective well being after gentamicin treatment(Immediate time after gentamicin treatment (2weeks))
- Differences of perceived dizziness after surgery(6 months after surgery)
- Differences of perceived anxiety/depression after surgery(6 months after surgery)
- Change of level of perceived dizziness after surgery as compared to before surgery(At first vestibular assessment (inclusion) and 6 months after surgery)