Optimal dose of simethicone administration for enhancing visibility prior to upper endoscopy A randomized, double blinded, placebo multicenter controlled trial
Phase 2
- Conditions
- Mucosal visibility on EGDEndoscopic mucosal visibility, Esophagogastroduodenoscopy (EGD), Simethicone dosages
- Registration Number
- TCTR20240515001
- Lead Sponsor
- Internal medicine department, Suratthani Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 273
Inclusion Criteria
1. Chronic dyspepsia, 2. Dysphagia, 3. Esophageal varices surveillance, 4. Anemia, 5. Weight loss, 6. Vomiting, 7. Gastroesophageal reflux disease symptoms
Exclusion Criteria
1. Upper GI bleeding, 2. Peritonitis, 3. Esophageal stricture or gastric outlet obstruction, 4. Active cardiac condition or respiratory failure, 5. Pregnancy or lactation, 6. Previous history of abdominal surgery, 7. Allergy to simethicone, 8. Not cooperate to perform an EGD
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mucosal visibility During performing an EGD mucosal visibility score
- Secondary Outcome Measures
Name Time Method Add-on volume of simethicone for rescue mucosal visibility During performing an EGD procedure Volume of liquid simethicone combine with normal saline for flushing ,Duration of EGD procedure After complete exam and scope withdrawal from patient Duration of EGD procedure (minutes-seconds),Patient's satisfaction Within 30 minutes after finishing EGD procedure Visual analogue scale (0-10),Patient's safety During the study period Complications of EGD procedure and adverse effects of simethicone