A Double-blind Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness
Recruitment status was Recruiting
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||A Double-blind Randomized Placebo Controlled Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness|
- Finding more effective treatment to the motion sickness symptoms during and after simulator training. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||September 2010|
|Estimated Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198106
|Contact: Amit Assa, Dr.||03-7379142|
|base 30 IAF||Recruiting|