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

ConditionsEsophagogastroduodenoscopySimethiconeN-AcetylcysteinePremedicationVisualizationEsophagogastroduodensocopy (EGD) ProcedurePlacebo - ControlGastritis Associated With Helicobacter PyloriTumor GastricLesions in the Esophagus, Stomach, Duodenum or Rectum
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorHospital General de Mexicali

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Premedication with n-acetylcysteine

    Drug

    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.

  • Placebo (drinking water)

    Drug

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

  • Premedication with simethicone

    Drug

    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

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: Patients receiving n-acetylcysteine/simethiconeActive comparator 2 interventions
Group B: Patients receiving placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total score on the Toronto Upper Gastrointestinal Cleaning Score (TUGCS)

The Toronto Upper Gastrointestinal Cleaning Score (TUGCS) is a validated scale that assesses mucosal cleanliness/visualization across four upper GI areas (fundus, body, antrum, and duodenum). Each area is scored from 0 to 3 (0 = poorest visualization; 3 = entire mucosa visible without suctioning/washing). The total score is the sum of all four areas (range 0-12). Higher scores indicate better mucosal cleanliness/visibility. Scoring is performed by blinded assessors during the procedure using standardized criteria.

Time frame
During the index upper endoscopy (Day 0), scored intra-procedure (≈20-60 minutes after premedication).

Secondary outcomes

1

Detection of Mucosal Lesions

Number of patients in whom mucosal lesions are detected during the procedure.

Time frame
During endoscopy procedure
2

Complete Esophageal Visualization

Binary assessment (Yes/No) of whether complete esophageal visualization was achieved.

Time frame
During endoscopy.
3

Histological gastritis according to the Updated Sydney System (0-3 per item) and OLGA/OLGIM staging (0-IV)

Measurement tool: Updated Sydney System (sum of domains not mandatory). Sites and technique: 5 gastric biopsies according to the Sydney protocol (2 antrum, 2 body, 1 incisura angularis), fixed in formalin; H\&E and Giemsa staining (or IHC if necessary for H. pylori). Domains and ranges (each 0-3): H. pylori density: 0 = absent, 1 = mild, 2 = moderate, 3 = marked. Chronic inflammation (mononuclear): 0-3. Activity (neutrophils): 0-3. Glandular atrophy: 0-3. Intestinal metaplasia: 0-3. Minimum-maximum range per domain: 0-3; higher scores = worse histological severity. Risk staging: OLGA (0-IV) for atrophy, OLGIM (0-IV) for intestinal metaplasia; higher stages = worse stage/higher risk. Reported measure: distribution of scores per domain (0-3) and proportion per OLGA/OLGIM stage (0-IV), comparing arms.

Time frame
Biopsies obtained during the index endoscopy (Day 0); histopathological report within 14 days
4

Presence and density of Helicobacter pylori by histology (Updated Sydney System 0-3)

Measurement tool: Updated Sydney System for H. pylori. Range and direction: 0-3 (0 = not detected; 1 = mild; 2 = moderate; 3 = marked). Higher scores = higher bacterial density. Technique: H\&E + Giemsa staining (or IHC if indeterminate). Reported measure: Proportion of patients positive for H. pylori (≥1 on the scale), and Distribution of categories 0-3 per arm.

Time frame
Biopsies obtained during the index endoscopy (Day 0); report within 14 days

Other outcomes

Sponsors and contacts

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Hospital General de Mexicali

Lead sponsor

Source ClinicalTrials.gov
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