A Study to Evaluate Endoscopic Visibility of Stomach After a Combination Drink of N-acetylcysteine and Simethicone

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Endoscopy is the diagnostic modality for most gastroduodenal diseases. During endoscopy mucus and foam may actually interfere with the visibility of the stomach mucosa. So the mixture of mucolytic ( N-acetyl cysteine) and anti-foaming agents ( simethicone) agents may disperse the bubbles and mucus in the stomach and enhance gastric visibility. This unique combination drink given 20-30 minutes prior to endoscopy is absolutely safe. There are previous studies from India, which was retrospective study. So, we have planned to conduct this randomized controlled trial on this issue. Adult patients undergoing diagnostic endoscopy will be randomized and one group (100 patients) will be given the combination drink whereas another group 9100 patients) will undergo an endoscopy after overnight fasting only, as a placebo drink may actually hamper the endoscopic visibility. Our primary outcome, gastric visibility will be assessed using a standard visibility scoring system.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences

Criteria

Inclusion Criteria:

1. Consecutive patients presenting for ambulatory diagnostic endoscopy

2. Willing Informed consent

3. Age 18-75 years

Exclusion Criteria:

1. Patients undergoing therapeutic endoscopy

2. Patients undergoing emergency endoscopy

3. Deeply sedated & anesthetized patients

4. Pregnant patients

5. Clinically suspected motility disorders (gastroparesis, achalasia)

6. Patients with esophageal stricture

7. Patients with gastric outlet obstruction.