Small Volume Simethicone Before Gastroscopy: Any Benefit?

NCT ID: NCT02555228

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-11-30

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.

Conditions

Lesion of Stomach

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Simethicone premedication

Liquid simethicone (1ml volume) in 5mls of water

Group Type: EXPERIMENTAL

Simethicone

Intervention Type: DRUG

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

Placebo

Just 5 mls of water

Group Type: PLACEBO_COMPARATOR

Water

Intervention Type: OTHER

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

Interventions

Simethicone

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

Intervention Type: DRUG

Water

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Changi General Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

CGH-QIPSMJ

Identifier Type: -

Identifier Source: org_study_id