NCT02576340
Completed
Phase 4
Spasmolytic (Otilonium Bromide) Use in Upper Gastrointestinal Endoscopy: Randomized Prospective Trial
Overview
- Phase
- Phase 4
- Intervention
- otilonium bromide
- Conditions
- Gastroscopy
- Sponsor
- Konya Meram State Hospital
- Enrollment
- 400
- Primary Endpoint
- motility
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Upper gastrointestinal system endoscopy is widely used for diagnostic approach. To increase the tolerability and compliance of the patient, sedation is applied. There are many studies showing that sedation increases the patient compliance and the tolerability. However, spasmolytic use in GE has not been evaluated yet.
Investigators
barış sevinç
M. D.
Konya Meram State Hospital
Eligibility Criteria
Inclusion Criteria
- •no hypersensitivity to the agent.
Exclusion Criteria
- •Emergent cases,the cases with low mental compatibility and pregnant women were excluded from the study. Moreover, the procedures under sedation, cases with disorders decreasing the intestinal motility like hypothyroidism and diabetes were excluded.
Arms & Interventions
study
drug was administered
Intervention: otilonium bromide
Outcomes
Primary Outcomes
motility
Time Frame: 3 months
decrease in motility during the procedure (number of peristaltic moves in a minute)
Secondary Outcomes
- patient tolerance(3 months)
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