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OpenTrials
Completed

NCT Number: NCT02576340

Spasmolytic in Upper Gastrointestinal Endoscopy

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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Key information

Conditions

Gastroscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

otilonium bromide

Drug

otilonium bromide was administered before the procedure

Primary outcomes

  1. motility

    Time frame: 3 months

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

Secondary outcomes

  1. patient tolerance

    Time frame: 3 months

    patient tolerance will be determined by questionnaire

Sponsors and collaborators

Lead sponsor

Konya Meram State Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 15, 2015
Registry last updated
Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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