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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Medical Corps, Israel Defense Force.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier:
NCT01198106
First received: September 8, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

September 8, 2010
September 8, 2010
September 2009
September 2010   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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A Double-blind Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness
A Double-blind Randomized Placebo Controlled Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness

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
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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Simulator Sickness
  • Drug: scopolamine
    0.6 mg
    Other Name: kwells
  • Drug: cinnarizine
    50 mg
    Other Name: stonoron
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
21 Years to 50 Years
Yes
Contact: Amit Assa, Dr. 03-7379142
Israel
 
NCT01198106
792-2008-IDF-CTIL
No
Amit Assa MD, IAF aeromedical center
Medical Corps, Israel Defense Force
Not Provided
Not Provided
Medical Corps, Israel Defense Force
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP