Randomized Controlled Trial to Assess N-acetylcysteine and Simethicone Premedication for Mucosal Visibility During Elective Upper Gastrointestinal Endoscopy Using the TUGS Score

What this Trial Is About

Researchers are evaluating whether a combination of N-acetylcysteine and simethicone can improve the cleanliness of the mucosal surface during upper gastrointestinal endoscopy in adults aged 18 to 99 years. This randomized, double-blind, placebo-controlled phase 2 trial includes both healthy individuals and those with non-bleeding gastrointestinal symptoms. The study aims to determine if this combination enhances mucosal visibility based on the Toronto Upper Gastrointestinal Cleanliness Score (TUGS) and to assess its safety and tolerability in this population. Participants will be randomly assigned to receive a single oral dose of either N-acetylcysteine (600 mg) combined with simethicone (100 mg) or a placebo (water) 20 to 60 minutes before undergoing a routine upper gastrointestinal endoscopy. Both participants and endoscopists will be blinded to the treatment allocation. The study will compare mucosal visibility scores between the two groups and monitor for any adverse effects or intolerance related to the premedication. During the study, participants will undergo the scheduled endoscopy where endoscopists will evaluate mucosal cleanliness using the TUGS scoring system. Additional data such as age, sex, body mass index, fasting duration, and endoscope model will be recorded for analysis. Researchers will also document any significant endoscopic findings, histological diagnoses, and the presence of Helicobacter pylori infection. Safety monitoring will be conducted throughout the procedure and follow-up, with all data collected anonymously for statistical evaluation.

Premedication With N-acetylcysteine and Simethicone to Improve Mucosal Visualization in Elective Upper Endoscopy