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

• Status: Completed
• Trial end date: 2017-12-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Keimyung University Dongsan Medical Center

Criteria

Inclusion Criteria:

• patients who perform non-sedative endoscopy for diagnosis or screening purposes.

• patients who understand and follow the directions and questionnaires of clinical trials.

• patients who have decided to voluntarily participate in this clinical trial and have agreed in writing

Exclusion Criteria:

• Patients who performed Upper GI surgery.

• Severe gastric outlet obstruction or malformations or gastroparesis

• Patients who have severe cognitive impairment

• Pregnant or lactation patients

• Patients who need to hemostasis for upper GI bleeding

• Hemodynamic unstable patients

• Above American Society of Anesthesiology classification class 4