Colonoscopy
Conditions
Keywords
Colonoscopy, Anticholinergics
Brief summary
Usefulness of Flospan as a premedication for colonoscopy: A randomized double-blind controlled trial
Detailed description
Cimetropium bromide is premedication of colonoscopy. However, it is contraindication for some diseases; benign prostatic hyperplasia(BPH) or other obstructive uropathy, intestinal obstruction, pyloric stenosis, glaucoma, myasthenia gravis, megacolon, paralytic ileus. In this cases, Flospan (phloroglucin) is effective alternative drug. So our research was to compare the effects of these two drugs.
Interventions
DRUGPhloroglucin
Premedication of colonoscopy
DRUGCimetropium bromide
Premedication of colonoscopy
PROCEDUREColonoscopy
Diagnostic examination of colon
DRUGPlacebo
Placebo for double-blind study These are harmless to the human body, and are composed of saline solution without drug efficacy.
Sponsors
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Recipient endoscopic diagnostic purposes.
Exclusion criteria
* If you currently pregnant, or of childbearing potential * Previous abdominal surgery or bowel resection. * If under 18 years of age * If the last two days, the administration of anticholinergic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non inferiority of phloroglucin to cimetropium bromide | Up to ten months | Comparing the two groups of time of examination, frequency of peristalsis, Scoring for the experimenter and the subject of the inspection feedback, double-blind setting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total diagnostic colonoscopy exam time | 1 year | — |
| Evaluation of practitioners | 1 year | Colonic motility and test difficulty |
| Evaluation of subjects | 1 year | The degree of discomfort after test |
| Total dose and times of sedatives for pain control | 1 year | Total dose and times of sedatives (midazolam, propofol) for pain control |
| Time of cecal intubation | 1 year | Total time of colonoscope intubation from anus to cecum |
| Peristalsis time of transverse colon | 1 year | Total peristalsis time of transverse colon for two minutes |
Other
| Measure | Time frame |
|---|---|
| Bowel cleansing status | 1 year |
| Heart rate, respiratory rate, oxygen saturation, blood pressure | 1 year |
Countries
South Korea
Contacts
Primary ContactKee Myung Lee, M.D., Ph.D.
Backup ContactSun Gyo Lim, M.D.
Outcome results
None listed