MedTrace Logo

Pre-medication With N-acetylcysteine and Simethicone to Improve Mucosal Visibility During Gastroduodenoscopy

NCT05951712 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2023-07-24

No results posted yet for this study

Summary

In this study, we aimed to compare combined premedication with simethicone or N-acetylcysteine (NAC) for mucosal visualisation during esophagogastroduodenoscopy (EGD).

The primary outcome of the study was comparison of total mucosal visibility score (TMVS) between combined pre-medication (Simethicone+ NAC) and individual pre-medication groups (Simethicone and NAC) in patients undergoing EGD. Secondary outcomes included comparison of TMVS between different groups, TMVS in early (10-20 min) versus late (\>20-30 min) endoscopy groups, adequate gastric mucosal visibility, detection of lesions and adverse events related to the pre-medications. Adequate and inadequate gastric mucosal visibility was defined as a cumulative score of \<7 and ≥7, respectively.

Conditions

  • Mucosal Erosion

Interventions

DRUG

Simethicone 150mg

Impact of simethicone on the mucosal visibility of stomach and duodenum

DRUG

N Acetyl cysteine 600mg

Impact of N Acetyl cysteine on the mucosal visibility of stomach and duodenum

DRUG

Simethicone 150mg plus N Acetyl cysteine 600 mg

Impact of simethicone plus N Acetyl cysteine on the mucosal visibility of stomach and duodenum

OTHER

Placebo

Impact of water on the mucosal visibility of stomach and duodenum

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Zaheer Dr Nabi, MD · ASIAN INSTITUTE OF GASTROENTEROLOGY/AIG HOSPITALS

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-16
Primary Completion
2022-08-20
Completion
2022-11-04

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05951712 on ClinicalTrials.gov