Actively Recruiting
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
Eligibility Criteria
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.
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
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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