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Completed

NCT Number: NCT02555228

Small Volume Simethicone Before Gastroscopy: Any Benefit?

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.

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Key information

Conditions

Lesion of Stomach

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Changi General Hospital

Singapore, 529889

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Planned for an elective diagnostic gastroscopy by the attending gastroenterologist
  • Age of at least 21 years old
  • Mentally competent and able to provide informed consent

Exclusion criteria

  • Category A patients (incarcerated prisoners)
  • adults who are unable to give their own informed consent due to lack of mental capacity
  • suspected gastrointestinal bleeding
  • suspected impacted foreign material
  • suspected gastric outlet obstruction
  • suspected esophageal obstruction
  • history of dysphagia
  • known hypersensitivity to simethicone
  • previous gastrectomy

Treatment and study plan

Simethicone

Drug

100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.

Water

Other

5mls of water is given at least 30 minutes before the gastroscopy.

Primary outcomes

  1. Total Cumulative Mucosal Visibility Score

    Time frame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.

    Total cumulative mucosal visibility score (TMVS) of all areas during the gastroscopy as determined by Mc Nally score:

    Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured

    Total areas covered:

    (E) esophagus (D) duodenum (A) Antrum and angularis (B) body and fundus

Secondary outcomes

  1. Mucosal Visibility Score Per Area as Determined by Mc Nally Score:

    Time frame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.

    • Area E: esophagus
    • Area D: duodenum
    • Area A: antrum and angularis
    • Area B: body and fundus

    Mc Nally score per area:

    Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured

  2. Volume of Additional Manual Flushes Required During Endoscopy in Mls

    Time frame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.

    The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles.

  3. Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution

    Time frame: Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Official study title

Benefits of Premedication With Small Volume Simethicone Solution Before Diagnostic Gastroscopy: A Randomized Endoscopist-blinded Prospective Study

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 21, 2015
Registry last updated
Mar 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.