A Phase 2/3 interventional study of Simethicone and Water in Lesion of Stomach, sponsored by Changi General Hospital. Completed at 1 site in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2016-03-15.
Sponsored by Changi General Hospital · Phase 2/3 and Interventional
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.
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.
Changi General Hospital is the lead sponsor of 101 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Liquid simethicone (1ml volume) in 5mls of water
Drug: Simethicone
Just 5 mls of water
Other: Water
100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.
5mls of water is given at least 30 minutes before the gastroscopy.
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
Time frame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.
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
Time frame: 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.
Time frame: 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
Time frame: Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours
| Milestone | Simethicone Premedication | Placebo |
|---|---|---|
| Started | 27 | 27 |
| Completed | 27 | 27 |
| Not completed | 0 | 0 |
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
| units | Simethicone Premedication | Placebo |
|---|---|---|
| Total Cumulative Mucosal Visibility Score | 5.78 ± 1.65 | 8.89 ± 1.97 |
* 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
| units on a scale | Simethicone Premedication | Placebo |
|---|---|---|
| Area E (esopahgus) | 1.48 ± 0.57 | 1.59 ± 0.57 |
| Area D (duodenum) | 1.26 ± 0.53 | 2.26 ± 0.81 |
| Area A (antrum and angularis) | 1.30 ± 0.54 | 2.56 ± 1.05 |
| Area B (body and fundus) | 1.74 ± 0.81 | 2.44 ± 0.97 |
The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles.
| mls | Simethicone Premedication | Placebo |
|---|---|---|
| Volume of Additional Manual Flushes Required During Endoscopy in Mls | 3.89 ± 11.46 | 84.81 ± 110.18 |
| number of events | Simethicone Premedication | Placebo |
|---|---|---|
| Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution | 0 | 0 |
Collected over Any adverse event that occurs during the study period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Simethicone Premedication | — | 0/27 (0%) | 0/27 (0%) |
| Placebo | — | 0/27 (0%) | 0/27 (0%) |
| Age, Customized(years) | Simethicone Premedication | Placebo | Total |
|---|---|---|---|
| Age | 57.7 ± 12.5 | 52.9 ± 15.5 | 55.3 ± 14 |
| Sex/Gender, Customized(participants) | Simethicone Premedication | Placebo | Total |
|---|---|---|---|
| Male patients | 15 | 9 | 24 |
| Female patients | 12 | 18 | 30 |
| Region of Enrollment(participants) | Simethicone Premedication | Placebo | Total |
|---|---|---|---|
| Singapore | 27 | 27 | 54 |
| Mean premedication time (min:sec)(seconds) | Simethicone Premedication | Placebo | Total |
|---|---|---|---|
| Mean | 2686 ± 756 | 2468 ± 596 | 2577 ± 676 |
Plan to share: Yes — Data send to Singapore Health Sciences Authority
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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Simethicone