Small Volume Simethicone Before Gastroscopy: Any Benefit?

Lesion of Stomach Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555228
• Other study ID #: CGH-QIPSMJ
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2015
• Last updated: February 15, 2016
• Start date: August 2015
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Lesion of Stomach

Intervention

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

Other:
• Water
5mls of water is given at least 30 minutes before the gastroscopy.

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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	No