Spasmolytic in Upper Gastrointestinal Endoscopy

Phase 4

Completed

• Conditions: Gastroscopy
• Interventions: Drug: otilonium bromide

• Registration Number: NCT02576340
• Lead Sponsor: Konya Meram State Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Status Verified: 2015-10
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-14
• Last Update Submitted: 2015-10-14
• Study First Posted: 2015-10-15
• Last Update Posted: 2015-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study	otilonium bromide	drug was administered

Primary Outcome Measures

Name	Time	Method
motility	3 months	decrease in motility during the procedure (number of peristaltic moves in a minute)

Secondary Outcome Measures

Name	Time	Method
patient tolerance	3 months	patient tolerance will be determined by questionnaire