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
  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

Resource links provided by NLM:


Further study details as provided by Medical Corps, Israel Defense Force:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Drug: scopolamine
    0.6 mg
    Other Name: kwells
    Drug: cinnarizine
    50 mg
    Other Name: stonoron
  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198106

Contacts
Contact: Amit Assa, Dr. 03-7379142

Locations
Israel
base 30 IAF Recruiting
Yavne, Israel
Sponsors and Collaborators
Medical Corps, Israel Defense Force
  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:
Cinnarizine
Butylscopolammonium Bromide
Scopolamine Hydrobromide
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Adjuvants, Anesthesia
Central Nervous System Agents
Mydriatics

ClinicalTrials.gov processed this record on October 19, 2014