Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery: a randomized multi-center phase III trial - AkNiPro2

niversitätsklinikum Halle Saale, Klinik und Poliklinik für Neurochirurgie0 个研究点目标入组 336 人开始时间: 2020年5月8日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1.Male and female adults age = 18 years
•2.Vestibular schwannomas (Koos I-IV) with indication for surgery
•3.Preoperative pure-tone audiogram (not older than 3 months prior to surgery), hearing function according to Gardner-Robertson scale (GR) 1-3 (Air-conduction PTA (0.5-3kHz) <90 dB HL)
•4.Preoperative MRI (not older than 6 months prior to surgery)
•5.Written informed consent obtained according to international guidelines and local laws
•6. Ability to understand and give informed consent.
•7.Safe contraception measures for males and females. Procedures with a pearl index of less than 1% apply as safe pregnancy prevention measures.

•1. Hearing function GR 4-5 (Air-conduction PTA (0.5-3kHz) >=90 dB HL)
•2. conductive hearing loss at affected side (mean air-bone gap (0.5, 1, 2, 3 kHz) >10 dB) if
•bone-conduction is measurable
•3. Previously irradiated or surgical treated VS
•4. Neurofibromatosis, other brain tumors, other reasons for inoperability
•5. Pregnancy and lactation period
•6. Known hypersensitivity to nimodipine or any of the excipients (ethanol, Macrogol, sodiumcitrate, citric acid) to be used for nimodipine infusion
•7. History of (reformed alcoholics) or persistent abuse of alcohol
•8. Known current kidney or liver insufficiency
•9. Any medical condition that in the opinion of the investigator would not permit
•participation in the clinical trial.
•10. Unstable angina pectoris and/or Myocardial infarction during the last four weeks before
•start of treatment
•11. severe, uncontrolled, symptomatic hypotension at inclusion
•12. Subjects with psychological, psychiatric, neurological, familial, sociological, or
•geographical conditions that do not permit compliance with the protocol as well as
•officially and/or legally accomodated persons
•13. Participation in another interventional trial simultaneously and within the last 30 days
•prior to inclusion (registries or observational studies allowed)

发起方

niversitätsklinikum Halle Saale, Klinik und Poliklinik für Neurochirurgie