Impact of Timing of Premedication on Mucosal Visibility During Endoscopy-A Randomized Controlled Trial (ENDO)

Impact of Timing of Premedication on Mucosal Visibility During Endoscopy

UGI endoscopy(esophagogastroduodenoscopy) is the main diagnostic modality for direct visualization ,real time assessment and interpretation of findings encountered. The evaluation of esophagogastroduodenoscopy (EGD) quality measures encompasses several categories, such as structure, procedure, result, and adverse events. The peri-EGD period procedures fall under the procedural area, which is primarily concerned with preventing and minimising missed diagnoses.

. More aid in the identification and characterisation of gastrointestinal mucosal lesions is provided by endoscopes equipped with improved imaging technologies, such as multiband or narrow-band imaging (NBI). Despite these advancements of technological aspects, the unclean mucosal surface of the stomach can make these high-end pieces of equipment virtually useless To visualize properly and diagnose accurately there should be clear visibility of mucus apart from operator experience. Since the stage at diagnosis of upper gastrointestinal cancer is a major factor in survival, early detection is essential in improving the prognosis of patients the main factors responsible for hinderance of mucosal visibility are mucus foam and bubbles, which requires additional care for the clearance to enhance the vision and also decrease endoscopy duration by alleviating the need of repeated flushing and suctioning during endoscopy. The froth and bubbles are made of mucous secretions mixed with gastric juice and bile. Simethicone (polydimethylsiloxane and silicon dioxide) has been proven to be a promising defoaming agent as an endoscopic premedication in removing bubbles . Simethicone works by reducing the surface tension of air bubbles, and releases the trapped air by causing small bubbles to coalesce and collapse . N-acetylcysteine (nac), a mucolytic agent, has also been used as premedication acts by removing the mucous overlying the gastrointestinal mucosa 4-point scale described by Basford et al

1. No adherent mucus and clear views of the mucosa.
2. A thin coating of mucus that did not obscure views of the mucosa.
3. Some mucus/bubbles partially obscuring views of the mucosa (i. E. A small mucosal lesion might be missed without flushing
4. Heavy mucus/bubbles obscuring views of the mucosa (i. E. Extensive flushing is needed to avoid missing small mucosal lesions)

Study Overview

• Status: Completed
• Conditions: Endoscopy, Digestive System
• Intervention / Treatment: Drug: Simethicone plus NAC

Detailed Description

Procedure

• Premixed medication (150mg simethicone and 600mg nac with 100ml of water) was given at specified timing Primary objective - comparison of mucosal visibility between 4 groups Secondary objectives - adverse events adequate gastric mucosal visibility lesion detection rate

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Asian Institute of Gastroenterology /Aig Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Age >18years

Exclusion Criteria:

• History of upper gastrointestinal surgery
• Neurological disorders with impaired swallowing
• Active gastrointestinal bleeding,
• Caustic ingestion
• Pregnancy.
• Known history of multiple allergies
• Gastric outlet obstruction
• Esophageal motility disorders
• Contraindication for upper GI endoscopy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; Normal endoscopic patients with out medication is required to compare with active groups.
Experimental: simethicone plus NAC combination time interval greater than 30 minutes; Premixed medication (150mg) simethicone and 600mg nac with 100ml of water has to be given >30minutes for 273 patients.	Drug: Simethicone plus NAC; Drug simethicone plus N acetylcysteine will be given before endoscopy with different time intervals; Other Names: placebo (water)
Experimental: simethicone plus NAC 10 to 20 minutes; Premixed medication (150mg) simethicone and 600mg nac with 100ml of water has to be given 10-20 minutes time interval for 273 patients.	Drug: Simethicone plus NAC; Drug simethicone plus N acetylcysteine will be given before endoscopy with different time intervals; Other Names: placebo (water)
Experimental: simethicone plus NAC 20 to 30 minutes; Premixed medication (150mg) simethicone and 600mg nac with 100ml of water has to be given 20-30minutes for 273 patients.	Drug: Simethicone plus NAC; Drug simethicone plus N acetylcysteine will be given before endoscopy with different time intervals; Other Names: placebo (water)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of mucosal visibility between 4 groups	Scores will be given based on Basford scale for esophagus, stomach (four parts: Cardia, fundus, body, antrum), Duodenum (D1, D2), score 1 indicates No adherent mucus and clear views of the mucosa, score 2 indicates A thin coating of mucus that did not obscure views of the mucosa, score 3 indicates some mucus/bubbles partially obscuring views of the mucosa score 4 indicates Heavy mucus obscuring views of the mucosa .	10-30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To check adverse events during medication	adverse events may happen due to simethicone medicine like itching etc	30 minutes
To identify the lesion detection rate	During endoscopy procedure with different time intervals the lesions were noted	30 minutes

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: zaheer Dr Nabi, MBBS MD DNB, Asian Institute of Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): February 18, 2025
• Study Completion (Actual): April 29, 2025

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 3, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Emollients; Antifoaming Agents; Simethicone
• Other Study ID Numbers: POMVDE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No