Effect of Oral Phloroglucin (Flospan®) as Premedication of Non-sedative Diagnostic Esophagogastroduodenoscopy
Condition: Anti-spasmodics; Gastric Peristalsis; Non-sedative Endoscopy
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Background : Endoscopy is currently widely regarded as the most important test in diagnosing
      stomach disorders, including stomach cancer. Gastric peristalsis, which occurs during the
      endoscopic procedure, limits the visual filed of the inspection, 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 endoscopy because
      intravenous assessment is unnecessary. In addition, these drugs were reported the side
      effects including thirst, dysuria, transient visual filed defect, tachycardia, anxiety so
      were not recommended for patients with benign prostatic hyperplasia, glaucoma, old age.
      Actually patients who undergo non-sedative endoscopy are used to perform examinations without
      using anti-spasmodics. In this case, gastric peristalsis restricts endoscopist's visibility
      and making accurate observation and prolonged inspection time increases patient's discomfort.
      For comfort and successfull test, anti-spasmodics which don't have anti-cholinergic effect
      and are possible to take orally is necessary. Phloroglucin(Flospan®) prompts to release
      norepinephrine by impeding catecholamine O-methyl transferase enzymes in visceral smooth
      muscle, so it works to control spasm by normalizing smooth muscle movement which was
      accelerated by acetylcholine. 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.

      Aim : Analysis for the effects of Phloroglucin (Flospan ®) as pre-medication for non-sedative
      endoscopy

      Material and methods : This study is a single center, prospective, double blinded, randomized
      controlled trial that will be performed in Keimyung University Dongsan medical center. A
      total of 134 patients aged 18 to 80 are enrolled and patients were randomly assigned to the
      test group and the placebo group, taking the test drug or placebo 10 minutes before the
      endoscopy. The endoscopist records the degree of peristaltic movement and the degree of
      difficulty of the test at the start and end of the test. The degree of the peristalsis and
      the discomfort of the examination are evaluated by the scale used in the previous study. The
      questionnaire will be used to evaluate the patient's discomfort after drug administration,
      the taste of the drug, and the intention to re-use the drug.
    

Intervention name(s): Phloroglucin(Flospan®); Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): The experimental group was taken with Phloroglucin(Flospan®) before endoscopy.; The control group was treated with normal saline before endoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment