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Clinical Trials/NCT02576340
NCT02576340
Completed
Phase 4

Spasmolytic (Otilonium Bromide) Use in Upper Gastrointestinal Endoscopy: Randomized Prospective Trial

Konya Meram State Hospital0 sites400 target enrollmentJanuary 2013

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
June 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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