Spasmolytic in Upper Gastrointestinal Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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study

drug was administered

Group Type ACTIVE_COMPARATOR

otilonium bromide

Intervention Type DRUG

otilonium bromide was administered before the procedure

control

no drug administered

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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otilonium bromide

otilonium bromide was administered before the procedure

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No