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Recruiting Phase 2 NCT07245095

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

Trial Parameters

Condition Esophagogastroduodenoscopy
Sponsor Hospital General de Mexicali
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 132
Sex ALL
Min Age 18 Years
Max Age 99 Years
Start Date 2025-09-12
Completion 2026-11-30
Interventions
Premedication with n-acetylcysteinePlacebo (drinking water)Premedication with simethicone

Brief Summary

The goal of this randomized, double-blind, placebo-controlled clinical trial is to assess whether the combination of N-acetylcysteine and simethicone improves mucosal visibility during upper gastrointestinal endoscopy in adults aged 18 to 99 years of both sexes, including both healthy individuals and those with non-bleeding gastrointestinal symptoms. The main questions this study aims to answer are: Does pre-endoscopy administration of N-acetylcysteine/simethicone improve mucosal visualization based on the Toronto Upper Gastrointestinal Cleanliness Score (TUGS)? Is this combination safe and well tolerated in this patient population? Researchers will compare patients receiving N-acetylcysteine (600 mg) and simethicone (100 mg) orally 20-60 minutes before the procedure with those receiving placebo (water) to determine if there is a significant improvement in TUGS scores. Participants will: Receive a single oral dose of either N-acetylcysteine/simethicone or placebo prior to endoscopy Undergo a routine upper GI endoscopy Have mucosal cleanliness evaluated using the TUGS scoring system Be monitored for any adverse events or intolerance

Eligibility Criteria

Inclusion Criteria: * Men and women aged 18 to 70 years old. * Patients who agree to participate in the clinical trial. * Patients without active gastrointestinal bleeding. * Signing of informed consent form. Exclusion Criteria: * Patients with a history of hypersensitivity to N-acetylcysteine * Patients with a history of hypersensitivity to simethicone * Patients with a previous endoscopic diagnosis * Patients with a history of gastric or bariatric surgery * Patients with a history of motor disorders (e.g., scleroderma, diabetic gastroparesis) * Patients taking medications that delay gastric emptying (GLP-1 analogues) * Pregnant or breastfeeding patients * Patients who do not agree to participate in the clinical trial

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