Clinical trial NCT02555228: Small Volume Simethicone Before Gastroscopy: Any Benefit?
Official title: Benefits of Premedication With Small Volume Simethicone Solution Before Diagnostic Gastroscopy: A Randomized Endoscopist-blinded Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lesion of Stomach
Keywords: simethicone
gastroscopy
McNalley score
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2015-09-21
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Cumulative Mucosal Visibility Score
timeFrame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.
Secondary outcomes:
measure: Mucosal Visibility Score Per Area as Determined by Mc Nally Score:
timeFrame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.
measure: Volume of Additional Manual Flushes Required During Endoscopy in Mls
timeFrame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.
measure: Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution
timeFrame: Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
References: