Small Volume Simethicone Before Gastroscopy: Any Benefit?

• Sponsor: Changi General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02555228
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 17.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lesion of Stomach	Drug: Simethicone; Other: Water	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Official Title: Benefits of Premedication With Small Volume Simethicone Solution Before Diagnostic Gastroscopy: A Randomized Endoscopist-blinded Prospective Study
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Total Cumulative Mucosal Visibility Score [This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.]

   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

Secondary Outcome Measures

1. Mucosal Visibility Score Per Area as Determined by Mc Nally Score: [This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.]

   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

2. Volume of Additional Manual Flushes Required During Endoscopy in Mls [This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.]

   The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles.

3. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changi General Hospital	Singapore		Singapore	529889

Sponsors and Collaborators

• Changi General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Changi General Hospital
• ClinicalTrials.gov Identifier: NCT02555228
• Other Study ID Numbers: CGH-QIPSMJ
• First Posted: Sep 21, 2015
• Last Update Posted: Mar 15, 2016
• Last Verified: Feb 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Changi General Hospital: simethicone; gastroscopy; McNalley score
• Additional relevant MeSH terms: Simethicone

Study Results

Participant Flow

Arm/Group Title	Simethicone Premedication	Placebo
Arm/Group Description	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.	Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.
Period Title: Overall Study
STARTED	27	27
COMPLETED	27	27
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Simethicone Premedication	Placebo	Total
Arm/Group Description	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.	Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy.	Total of all reporting groups
Overall Participants	27	27	54
Age, Customized (years) [Mean (Standard Deviation) ]
Age	57.7 (12.5)	52.9 (15.5)	55.3 (14)
Sex/Gender, Customized (participants) [Number]
Male patients	15 55.6%	9 33.3%	24 44.4%
Female patients	12 44.4%	18 66.7%	30 55.6%
Region of Enrollment (participants) [Number]
Singapore	27 100%	27 100%	54 100%
Mean premedication time (min:sec) (seconds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [seconds]	2686 (756)	2468 (596)	2577 (676)

Outcome Measures

1. Primary Outcome

Title	Total Cumulative Mucosal Visibility Score
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simethicone Premedication	Placebo
Arm/Group Description	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.	Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.
Measure Participants	27	27
Mean (Standard Deviation) [units]	5.78 (1.65)	8.89 (1.97)

2. Secondary Outcome

Title	Mucosal Visibility Score Per Area as Determined by Mc Nally Score:
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simethicone Premedication	Placebo
Arm/Group Description	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.	Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.
Measure Participants	27	27
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)

3. Secondary Outcome

Title	Volume of Additional Manual Flushes Required During Endoscopy in Mls
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simethicone Premedication	Placebo
Arm/Group Description	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.	Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.
Measure Participants	27	27
Mean (Standard Deviation) [mls]	3.89 (11.46)	84.81 (110.18)

4. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Simethicone Premedication	Placebo
Arm/Group Description	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.	Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.
Measure Participants	27	27
Number [number of events]	0	0

Adverse Events

Time Frame	Any adverse event that occurs during the study period.
Arm/Group Title	Simethicone Premedication		Placebo
Arm/Group Description	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.		Just 5 mls of water Water: 5mls of water is given at least 30 minutes before the gastroscopy. 27 patients randomized to this group.
All Cause Mortality
	Simethicone Premedication		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Simethicone Premedication		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Simethicone Premedication		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.