About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Premedication with n-acetylcysteine
- Placebo (drinking water)
- Premedication with simethicone