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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorHospital General de Mexicali

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

Treatment groups

132 Participants
are divided into 2 treatment groups

Sponsors and collaborators