Actively Recruiting

Phase 2
Age: 18Years - 99Years
All Genders
Healthy Volunteers
NCT07245095

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

Led by Hospital General de Mexicali · Updated on 2025-11-24

132

Participants Needed

2

Research Sites

67 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Hospital Almater

Mexicali, Estado de Baja California, Mexico, 21000

Actively Recruiting

2

Hospital General de Mexicali

Mexicali, Estado de Baja California, Mexico, 21100

Actively Recruiting

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Research Team

L

Luis Andre Sanchez Perez, Resident

CONTACT

J

Jesus Alberto Camacho Escobedo, Gastroenterologist

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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