Spasmolytic in Upper Gastrointestinal Endoscopy

October 14, 2015 updated by: barış sevinç, Konya Meram State Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
motility
Time Frame: 3 months
decrease in motility during the procedure (number of peristaltic moves in a minute)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient tolerance
Time Frame: 3 months
patient tolerance will be determined by questionnaire
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Meram State Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (Estimate)

October 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ob002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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