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

NCT06581783 | Completed DMC

• 1 other identifier: POMVDE
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endoscopy, Digestive System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To check adverse events during medication

  30 minutes

• To identify the lesion detection rate

  30 minutes

Study Arms (4)

control

NO INTERVENTION

Normal endoscopic patients with out medication is required to compare with active groups.

simethicone plus NAC combination time interval greater than 30 minutes

EXPERIMENTAL

Premixed medication (150mg) simethicone and 600mg nac with 100ml of water has to be given \>30minutes for 273 patients.

Drug: Simethicone plus NAC

simethicone plus NAC 10 to 20 minutes

EXPERIMENTAL

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

simethicone plus NAC 20 to 30 minutes

EXPERIMENTAL

Premixed medication (150mg) simethicone and 600mg nac with 100ml of water has to be given 20-30minutes for 273 patients.

Drug: Simethicone plus NAC

Interventions

Simethicone plus NAC DRUG

Drug simethicone plus N acetylcysteine will be given before endoscopy with different time intervals

Also known as: placebo (water)

simethicone plus NAC 10 to 20 minutes; simethicone plus NAC 20 to 30 minutes; simethicone plus NAC combination time interval greater than 30 minutes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18years

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology /Aig Hospitals

Hyderabad, Telangana, 500082, India

Location

MeSH Terms

Interventions

Simethicone; Water

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• zaheer Dr Nabi, MBBS MD DNB

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: December 1, 2024
• Primary Completion: February 18, 2025
• Study Completion: April 29, 2025
• Last Updated: May 6, 2025

Record last verified: 2024-08

Locations

IN (1)