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

RECRUITINGPhase 2Sponsored by Hospital General de Mexicali
Actively Recruiting
PhasePhase 2
SponsorHospital General de Mexicali
Started2025-09-12
Est. completion2026-11-30
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted

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

Age: 18 Years – 99 YearsHealthy volunteers accepted
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

Conditions11

CancerEsophagogastroduodenoscopyEsophagogastroduodensocopy (EGD) ProcedureGastritis Associated With Helicobacter PyloriLesions in the Esophagus, Stomach, Duodenum or RectumN-AcetylcysteinePlacebo - ControlPremedicationSimethiconeTumor Gastric

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