A Double-blind Randomized Placebo Controlled Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Finding more effective treatment to the motion sickness symptoms during and after simulator training.
研究概览
简要总结
BACKGROUND:flight simulator have become an important component in pilot training. However, they are known to be associated with motion sickness like symptoms defined as Simulator Sickness (SS). Prevention countermeasures against motion sickness have been studied extensively focusing on cholinergic blockers and antihistamines. Most comparataive studies emphasized the effectiveness of scopolamine over outher agents. Evidence, though, on prophylaxis against SS is sparse.
OBJECTIVE: to assess the effectiveness of oral scopolamine versus oral cinnarizine or placebo for SS prevention in helicopter pilots.
DESIGN: a prospective, placebo controlled double-blind.
SETTING: Israel Air Forse (IAF) Helicopter Aircaft vWeapon System Trainer.
PARTICIPANTS: IAF experienced helicopter pilots.
INTERVENTION: 0.6 mg oral scopolamine or 50 mg oral cinnarizine or placebo 1 hour before beginning of a 3 sortie simulator training
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 21 to 50 years, qualified helicopter pilots
- •history of average TS score in SSQ more than 7.48
排除标准
- •known vestibular, visual or central nervous system pathology
- •fever of more than 37.2 degrees
- •any MS like symptom prior to simulator training
- •any compromising acute health problem
结局指标
主要结局
Finding more effective treatment to the motion sickness symptoms during and after simulator training.
时间窗: 1 year
To record a significant difference in motion sickness symptoms reduction during and after simulator training, after taking cinnarizine, scopolamine or placebo. We predict that scopolamine will prove to be more effective than cinnarizine with fewer side effects that can compromise pilot's performance during training.
次要结局
未报告次要终点