Spasmolytic in Upper Gastrointestinal Endoscopy

• Sponsor: Konya Meram State Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02576340
• Collaborator: (none)
• Enrollment: 400
• Arms: 2
• Duration (Months): 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroscopy	Drug: otilonium bromide	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: Spasmolytic (Otilonium Bromide) Use in Upper Gastrointestinal Endoscopy: Randomized Prospective Trial
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: study drug was administered	Drug: otilonium bromide; otilonium bromide was administered before the procedure
No Intervention: control no drug administered

Outcome Measures

Primary Outcome Measures

1. motility [3 months]

   decrease in motility during the procedure (number of peristaltic moves in a minute)

Secondary Outcome Measures

1. patient tolerance [3 months]

   patient tolerance will be determined by questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Konya Meram State Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: barış sevinç, M. D., Konya Meram State Hospital
• ClinicalTrials.gov Identifier: NCT02576340
• Other Study ID Numbers: ob002
• First Posted: Oct 15, 2015
• Last Update Posted: Oct 15, 2015
• Last Verified: Oct 1, 2015

• Additional relevant MeSH terms: Octylonium; Bromides

Study Results

No Results Posted as of Oct 15, 2015