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

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

Conditions

• Esophagogastroduodenoscopy
• Simethicone
• N-Acetylcysteine
• Premedication
• Visualization
• Esophagogastroduodensocopy (EGD) Procedure
• Placebo - Control
• Gastritis Associated With Helicobacter Pylori
• Tumor Gastric
• Lesions in the Esophagus, Stomach, Duodenum or Rectum

Interventions

DRUG

Premedication with n-acetylcysteine

Once the sample size has been calculated, patients who meet the inclusion criteria will be recruited. who will be randomized using the "Randomized for Clinical Trial" program for assignment to treatment groups A and B. Group A will receive 600 mg of N-acetylcysteine and 100 mg of simethicone orally 20 to 60 minutes before the procedure, while the control group will receive an equivalent placebo infusion (composed of drinking water). Premedication and placebo will be labeled in containers as medication or placebo by external personnel not involved in the study, and the identification of each bag will be noted on a sheet and kept in an envelope that will be opened at the end of the study. Tolerance will be evaluated. If any adverse events are identified, the principal investigator will be notified for action regarding the management of the adverse event and its reporting.

DRUG

Placebo (drinking water)

The control group will receive an equivalent placebo infusion (composed of drinking water)

DRUG

Premedication with simethicone

Once the sample size has been calculated, patients who meet the inclusion criteria will be recruited. who will be randomized using the "Randomized for Clinical Trial" program for assignment to treatment groups A and B. Group A will receive 600 mg of N-acetylcysteine and 100 mg of simethicone orally 20 to 60 minutes before the procedure, while the control group will receive an equivalent placebo infusion (composed of drinking water). Premedication and placebo will be labeled in containers as medication or placebo by external personnel not involved in the study, and the identification of each bag will be noted on a sheet and kept in an envelope that will be opened at the end of the study. Tolerance will be evaluated. If any adverse events are identified, the principal investigator will be notified for action regarding the management of the adverse event and its reporting

Sponsors & Collaborators

• Hospital General de Mexicali

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-12

Primary Completion

2026-11-30

Completion

2026-12-31

Countries

• Mexico

Study Locations