Small Volume Simethicone Before Gastroscopy: Any Benefit?

Phase 2

Completed

Conditions: Lesion of Stomach

Interventions: Drug: Simethicone
Other: Water

Registration Number: NCT02555228

Lead Sponsor: Changi General Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 54

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simethicone premedication	Simethicone	Liquid simethicone (1ml volume) in 5mls of water
Placebo	Water	Just 5 mls of water

Primary Outcome Measures

Name	Time	Method
Total Cumulative Mucosal Visibility Score	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 Outcome Measures

Name	Time	Method
Mucosal Visibility Score Per Area as Determined by Mc Nally Score:	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
Volume of Additional Manual Flushes Required During Endoscopy in Mls	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.
Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution	Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours