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A Double-blind Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness

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ClinicalTrials.gov Identifier: NCT01198106
Recruitment Status : Unknown
Verified September 2010 by Medical Corps, Israel Defense Force.
Recruitment status was:  Recruiting
First Posted : September 9, 2010
Last Update Posted : September 9, 2010
Sponsor:
Information provided by:
Medical Corps, Israel Defense Force

Brief Summary:

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 or disease Intervention/treatment Phase
Simulator Sickness Drug: scopolamine Drug: cinnarizine Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Double-blind Randomized Placebo Controlled Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness
Study Start Date : September 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: scopolamine
    0.6 mg
    Other Name: kwells
    Drug: cinnarizine
    50 mg
    Other Name: stonoron


Primary Outcome Measures :
  1. Finding more effective treatment to the motion sickness symptoms during and after simulator training. [ Time Frame: 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.



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198106


Contacts
Contact: Amit Assa, Dr. 03-7379142

Locations
Israel
base 30 IAF Recruiting
Yavne, Israel
Sponsors and Collaborators
Medical Corps, Israel Defense Force

Responsible Party: Amit Assa MD, IAF aeromedical center
ClinicalTrials.gov Identifier: NCT01198106     History of Changes
Other Study ID Numbers: 792-2008-IDF-CTIL
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: September 9, 2010
Last Verified: September 2010

Keywords provided by Medical Corps, Israel Defense Force:
simulator sickness
scopolamine
cinnarizine

Additional relevant MeSH terms:
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Cinnarizine
Adjuvants, Anesthesia
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics
Calcium Channel Blockers
Membrane Transport Modulators
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents