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Effect of Oral Phloroglucin (Flospan®) as Premedication of Non-sedative Diagnostic Esophagogastroduodenoscopy

NCT03342118 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-01-03

No results posted yet for this study

Summary

Gastric peristalsis, which occurs during the endoscopic procedure, limits the visual inspection of the inspection field, causing interference in the inspection. The actual endoscopic examination is most commonly used by injecting Hyoscine butylbromide(Buscopan®), Cimetropium bromide (Algiron ®) into intravenous or muscular injection so it is not suitable for patients who undergo non-sedative esophagogastroduodenoscopy. In addition, these drugs were reported the side effects including thirst, dysuria, transient visual filed defect, tachycardia, anxiety so were not recommended for benign prostate hyperplasia, glaucoma, old age patients. For comfort and succesfull test, anti-spasmodics which don't have anti-cholinergic effect and are possible to take orally is necessary. Phloroglucin(Flospan®) is a smooth muscle relaxant that is currently used in the anti-spasmodic treatment without anticholinergic action so it can be administered in patients with glaucoma or BPH. Also it is suitable for endoscopic premedication due to transparent liquid component. Therefore, in this study, we would like to confirm the efficacy and safety of Phloroglucin (Flospan ®), which can be taken orally, as an pre-medication for non-sedative endoscopy.

Conditions

  • Anti-spasmodics
  • Gastric Peristalsis
  • Non-sedative Endoscopy

Interventions

DRUG

Phloroglucin(Flospan®)

The experimental group was taken with Phloroglucin(Flospan®) before endoscopy.

DRUG

Normal saline

The control group was treated with normal saline before endoscopy

Sponsors & Collaborators

  • Keimyung University Dongsan Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-21
Primary Completion
2017-12-29
Completion
2017-12-29

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03342118 on ClinicalTrials.gov