Spasmolytic in Upper Gastrointestinal Endoscopy

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02576340

Enrollment

400

Registered

2015-10-15

Start date

2013-01-31

Completion date

2013-06-30

Last updated

2015-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroscopy

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.

Interventions

DRUGotilonium bromide

otilonium bromide was administered before the procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
patient tolerance	3 months	patient tolerance will be determined by questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026