Small Volume Simethicone Before Gastroscopy: Any Benefit?

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.

Study Overview

• Status: Completed
• Conditions: Lesion of Stomach
• Intervention / Treatment: Drug: Simethicone; Other: Water

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Changi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simethicone premedication; Liquid simethicone (1ml volume) in 5mls of water	Drug: Simethicone; 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.
Placebo Comparator: Placebo; Just 5 mls of water	Other: Water; 5mls of water is given at least 30 minutes before the gastroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Cumulative Mucosal Visibility Score	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	This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mucosal Visibility Score Per Area as Determined by Mc Nally Score:	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	This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.
Volume of Additional Manual Flushes Required During Endoscopy in Mls	The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles.	This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.
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

Collaborators and Investigators

• Sponsor: Changi General Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: September 13, 2015
• First Submitted That Met QC Criteria: September 18, 2015
• First Posted (Estimate): September 21, 2015

Study Record Updates

• Last Update Posted (Estimate): March 15, 2016
• Last Update Submitted That Met QC Criteria: February 15, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: gastroscopy; simethicone; McNalley score
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Antifoaming Agents; Emollients; Simethicone
• Other Study ID Numbers: CGH-QIPSMJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data send to Singapore Health Sciences Authority