Randomized Controlled Trial to Evaluate the Effect of Premedication With N-acetylcysteine and Simethicone on Mucosal Visibility During Elective Upper Gastrointestinal Endoscopy Using the TUGS Score

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Mexico
Hospital Almater
RECRUITING
Mexicali
Hospital General de Mexicali
RECRUITING
Mexicali
Contact Information
Primary
Luis Andre Sanchez Perez, Resident
sanchez.luis3@uabc.edu.mx
+ 52 6863468689
Backup
Jesus Alberto Camacho Escobedo, Gastroenterologist
jesus13camacho@hotmail.com
+ 52 6862146050
Time Frame
Start Date: 2025-09-12
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 132
Treatments
Active_comparator: Patients receiving n-acetylcysteine/simethicone
Placebo_comparator: Patients receiving placebo
Sponsors
Leads: Hospital General de Mexicali

This content was sourced from clinicaltrials.gov