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Simethicone Dosages with Minimal Normal Saline Solution Volume to Enhance Mucosal Visualization in Upper Endoscopy: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Simethicone Dosage with Minimal Normal Saline Solution Volume to Enhance Mucosal Visualization in Upper Endoscopy: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240515001
Enrollment
272
Registered
2024-05-15
Start date
2024-06-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucosal visibility on EGD Endoscopic mucosal visibility, Esophagogastroduodenoscopy (EGD), Simethicone dosages

Interventions

Patients in this arm will receive 2.4 ml of normal saline, drinking at 30 minutes before performing an EGD procedure ,Patients in this arm will receive 0.6 ml(40 mg) of liquid simethicone combine with
Placebo ,Simethicone 40 mg ,Simethicone 80 mg ,Simethicone 160 mg

Sponsors

The Gastroenterological Association of Thailand
Lead Sponsor
the Gastroenterological Association of Thailand.
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
mucosal visibility During performing an EGD mucosal visibility score

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactSereephap Saeung

Suratthani Hospital

guide101@gmail.com0815356574

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026