A Double-blind Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness
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Purpose
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
| Condition | Intervention |
|---|---|
|
Simulator Sickness |
Drug: scopolamine Drug: cinnarizine |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 100 |
| 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) |
-
Drug: scopolamine
Eligibility| Ages Eligible for Study: | 21 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- age 21 to 50 years, qualified helicopter pilots
- history of average TS score in SSQ more than 7.48
Exclusion Criteria:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Amit Assa MD, IAF aeromedical center |
| ClinicalTrials.gov Identifier: | NCT01198106 History of Changes |
| Other Study ID Numbers: | 792-2008-IDF-CTIL |
| Study First Received: | September 8, 2010 |
| Last Updated: | September 8, 2010 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Medical Corps, Israel Defense Force:
|
simulator sickness scopolamine cinnarizine |
Additional relevant MeSH terms:
|
Scopolamine Butylscopolammonium Bromide Cinnarizine Mydriatics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Parasympatholytics Calcium Channel Blockers Membrane Transport Modulators Cardiovascular Agents Histamine H1 Antagonists Histamine Antagonists Histamine Agents |
ClinicalTrials.gov processed this record on May 19, 2013