Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery and Its Neuroprotective Effect on the Cochlear and Facial Nerve Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- postoperative hearing
研究概览
简要总结
Vestibular schwannomas are primarily benign (WHO grade I) tumors originating from the Schwann cells of the vestibular nerve and are among the most common tumors of the skull base. Common treatment options are surgical tumor resection or targeted radiation therapy. The special challenge of surgical treatment is the functional preservation of the cranial nerves, especially the cochlear and facial nerves. Perioperative ischemia of the cochlea and cochlear nerve is postulated as the underlying mechanism of postoperative hearing loss. Ischemic preconditioning is a non-invasive procedure that triggers the release of vasoactive cytokines and mediators by repeated short-term induction of limb ischemia. Improved perfusion of critically perfused end organs as well as a reduction of cerebral infarct volumes has already been shown in other pathologies. In the planned study, possible neuroprotective effects of remote ischemic preconditioning on postoperative hearing as well as facial nerve function in patients with vestibular schwannomas will be examined.
详细描述
Purpose: Does remote ischemic preconditioning improve hearing and/or facial nerve palsy after resection of vestibular schwannomas?
Study Design: Prospective, randomized, double-blind, single-center.
Case number: The study should include 120 patients (60 treatment arm, 60 control arm). Case number calculation (mean effect sizes, chi-square test, alpha error = 0.05, beta error = 20%) results in a necessary total patient number of 100 with 50 patients per group. Including the expected dropout rate (approx. 20%), the required total number of study participants is set at 120 patients. With approximately 55 patients/year in whom anatomic preservation of the cochlear nerve is possible intraoperatively, the total study duration is estimated to be approximately 2-2.5 years.
Study procedure: Day 1
- Preoperative pure tone audiometry including speech discrimination and preoperative AEP measurement
- preoperative assessment of facial nerve function according to House and Brackmann and photo documentation
- Preoperative blood sample (Hg, WBC, platelet count, creatinine, sodium, potassium, CRP, PCT, IL-6, INR, Quick, aPTT, d-dimer)
- Evaluation of inclusion and exclusion criteria, informed consent
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
only the study nurse who performs the intervention is aware of the study arm
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
- •Age ≥ 18 years
- •total or gross-total resection of a vestibular schwannoma is planned
- •Functional hearing is still present on the affected side preoperatively (AEP evocable and Gardner-Robertson grade I, II, or III).
- •Preoperatively, facial function is unimpaired or mildly impaired (House and Brackmann grade I or II).
排除标准
- •Symptomatic peripheral artery disease.
- •Active or previous thrombosis in the extremity where the RIC procedure is to be performed.
- •Neurofibromatosis type 2
- •Only planned decompression of the internal auditory canal without relevant tumor resection
- •Pregnant or breastfeeding females
- •Previous radiotherapy of the vestibular schwannoma that will be resected
结局指标
主要结局
postoperative hearing
时间窗: 3 months (± 6 weeks) after surgery
hearing on pure tone audiometry according to AAO-HNS/Gardner-Robertson
次要结局
- postoperative facial nerve function(3 months (± 6 weeks) after surgery)