Clinical trial · Interventional
Premedication With N-acetylcysteine and Simethicone to Improve Mucosal Visualization in Elective Upper Endoscopy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophagogastroduodenoscopy | — | UNRESOLVED | — |
| Esophagogastroduodensocopy (EGD) Procedure | — | UNRESOLVED | — |
| Gastritis Associated With Helicobacter Pylori | — | UNRESOLVED | — |
| Lesions in the Esophagus, Stomach, Duodenum or Rectum | — | UNRESOLVED | — |
| N-Acetylcysteine | — | UNRESOLVED | — |
| Placebo - Control | — | UNRESOLVED | — |
| Premedication | — | UNRESOLVED | — |
| Simethicone | — | UNRESOLVED | — |
| Tumor Gastric | Gastric Neoplasm |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo (drinking water) | Drug | — | UNRESOLVED |
| Premedication with n-acetylcysteine | Drug | — | UNRESOLVED |
| Premedication with simethicone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Patients receiving n-acetylcysteine/simethicone
- interventionNames
- Drug: Premedication with n-acetylcysteine
- Drug: Premedication with simethicone
- type
- PLACEBO_COMPARATOR
- label
- Patients receiving placebo
- interventionNames
- Drug: Placebo (drinking water)
Primary outcomes (1)
- measure
- Total score on the Toronto Upper Gastrointestinal Cleaning Score (TUGCS)
- timeFrame
- During the index upper endoscopy (Day 0), scored intra-procedure (≈20-60 minutes after premedication).
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (8)
- BACKGROUNDDevereaux BM, Taylor ACF, Athan E, Wallis DJ, Brown RR, Greig SM, Bailey FK, Vickery K, Wardle E, Jones DM. Simethicone use during gastrointestinal endoscopy: Position statement of the Gastroenterological Society of Australia. J Gastroenterol Hepatol. 2019 Dec;34(12):2086-2089. doi: 10.1111/jgh.14757. Epub 2019 Jul 28. PMID 31242327
- BACKGROUNDManfredi G, Berte R, Iiritano E, Alicante S, Londoni C, Brambilla G, Romeo S, Menozzi F, Griffanti P, Brandi G, Moreschi O, Pezzilli R, Zullo A, Buscarini E. Premedication with simethicone and N-acetylcysteine for improving mucosal visibility during upper gastrointestinal endoscopy in a Western population. Endosc Int Open. 2021 Feb;9(2):E190-E194. doi: 10.1055/a-1315-0114. Epub 2021 Jan 25. PMID 33532557
- BACKGROUNDMonrroy H, Vargas JI, Glasinovic E, Candia R, Azua E, Galvez C, Rojas C, Cabrera N, Vidaurre J, Alvarez N, Gonzalez J, Espino A, Gonzalez R, Parra-Blanco A. Use of N-acetylcysteine plus simethicone to improve mucosal visibility during upper GI endoscopy: a double-blind, randomized controlled trial. Gastrointest Endosc. 2018 Apr;87(4):986-993. doi: 10.1016/j.gie.2017.10.005. Epub 2017 Oct 14. PMID 29037773
- BACKGROUNDBeaufort IN, Verbeek RE, Bosman JH, Al-Toma A, Bogte A, Alvarez Herrero L, Weusten BLAM. Optimal timing of simethicone administration prior to upper endoscopy: A multicenter, single-blind, randomized controlled trial. Endosc Int Open. 2023 Oct 17;11(10):E992-E1000. doi: 10.1055/a-2157-5034. eCollection 2023 Oct. PMID 37854124
- RESULTMahawongkajit P, Kanlerd A. A prospective randomized controlled trial comparing simethicone, N-acetylcysteine, sodium bicarbonate and peppermint for visualization in upper gastrointestinal endoscopy. Surg Endosc. 2021 Jan;35(1):303-308. doi: 10.1007/s00464-020-07397-8. Epub 2020 Feb 3. PMID 32016519
- RESULTChang WK, Yeh MK, Hsu HC, Chen HW, Hu MK. Efficacy of simethicone and N-acetylcysteine as premedication in improving visibility during upper endoscopy. J Gastroenterol Hepatol. 2014 Apr;29(4):769-74. doi: 10.1111/jgh.12487.