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

RecruitingPhase 2Ages 18 Years - 99 YearsAllHospital General de Mexicali
NCT07245095 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Premedication with n-acetylcysteine
  • Placebo (drinking water)
  • Premedication with simethicone
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Where

2 sites
Hospital Almater
Mexicali, Mexico
Hospital General de Mexicali
Mexicali, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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