Spasmolytic in Upper Gastrointestinal Endoscopy

Konya Meram State Hospital

Status and phase: Completed; Phase 4

Conditions: Gastroscopy

Treatments: Drug: otilonium bromide

Study type: Interventional

Funder types: Other

Identifiers

NCT02576340

ob002

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

study

Active Comparator group

Description:

drug was administered

Treatment:

Drug: otilonium bromide

control

No Intervention group

Description:

no drug administered