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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simethicone premedication | Experimental | Liquid simethicone (1ml volume) in 5mls of water |
|
| Placebo | Placebo Comparator | Just 5 mls of water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simethicone | Drug | 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy. |
|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mucosal Visibility Score Per Area as Determined by Mc Nally Score: |
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Singapore | 529889 | Singapore |
Data send to Singapore Health Sciences Authority
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| ID | Title | Description |
|---|---|---|
| FG000 | Simethicone Premedication | Liquid simethicone (1ml volume) in 5mls of water Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy. 27 patients randomized to this group. |
| FG001 | Placebo | Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy. 27 patients randomized to this group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Simethicone Premedication | Liquid simethicone (1ml volume) in 5mls of water Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units | This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes. |
|
Any adverse event that occurs during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simethicone Premedication | Liquid simethicone (1ml volume) in 5mls of water Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy. 27 patients randomized to this group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Song Mingjun | MOHH Holdings | 86337635 | mingjun.song0950c@gmail.com |
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| ID | Term |
|---|---|
| D012841 | Simethicone |
| D014867 | Water |
| ID | Term |
|---|---|
| D004129 | Dimethylpolysiloxanes |
| D012828 | Silicones |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
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| Water | Other | 5mls of water is given at least 30 minutes before the gastroscopy. |
|
| 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 |
Just 5 mls of water
Water: 5mls of water is given at least 30 minutes before the gastroscopy.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Mean premedication time (min:sec) | Mean | Standard Deviation | seconds |
|
| Placebo |
Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy. 27 patients randomized to this group. |
|
|
| Secondary | Mucosal Visibility Score Per Area as Determined by Mc Nally Score: |
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 | Posted | Mean | Standard Deviation | units on a scale | This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mls | This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes. |
|
|
|
| Secondary | Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution | Posted | Number | number of events | Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Placebo | Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy. 27 patients randomized to this group. | 0 | 27 | 0 | 27 |
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| D009930 |
| Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| Area A (antrum and angularis) |
|
| Area B (body and fundus) |
|