Lesion of Stomach Clinical Trial
Official title:
Benefits of Premedication With Small Volume Simethicone Solution Before Diagnostic Gastroscopy: A Randomized Endoscopist-blinded Prospective Study
A randomized controlled and endoscopist-blinded study which compares the efficacy of liquid simethicone (100mg) in 5 mls water, versus placebo ( 5mls of water), as premedication (given at least 30 minutes) before gastroscopy towards improvement of the total mucosal visibility score.
Excessive bubbles or foam during gastroscopy is a common problem which can cause significant
hindrance to an optimal evaluation of the gastric mucosa, prolong the procedure time, and
contribute to poor patient tolerance during the scope.
Simethicone, with or without N-acetylcysteine, has been extensively evaluated to improve
mucosal visibility. However, the volume of simethicone preparation and the timing of
ingesting this solution before gastroscope varied significantly across different studies. In
general, it appeared that a larger volume of simethicone solution, given earlier before the
gastroscopy, may yield better results. However, allowing a patient to ingest a large volume
of liquid before a gastroscopy under sedation brings forth the risk of aspiration. A recent
Taiwanese study published in 2014 [1] showed that the subgroup with 100mg of simethicone in
just 5ml of water, did achieve a good total mucosal visibility score, if the solution was
ingested more than 30 minutes before the gastroscope. This may be because a longer time
allows the simethicone to coat more of the mucosa. However, this study did not compare this
preparation against a placebo.
In Changi General Hospital, many gastroscopies are done daily with no premedication. Also,
there is no protocol for premedication before gastroscopes. This study hopes to prove that a
low volume of simethicone solution, given at an ample time (more than 30 minutes) before the
scope, can significantly improve overall endoscopy performance compared to no premedication
at all.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)