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Effectiveness of premedication with Dimethicone and N-acetyl cysteine for improving visibility during upper endoscopy

Protocol summary

Summary
This study aims to determine the effect of using either Dimethicone or N- acetyl cysteine prior to upper endoscopy to remove air bubbles, mucus and improve visibility. In this placebo controlled, double blind, randomized clinical trial, a total of 140 patients referred to endoscopy centers are enrolled after obtaining informed consent and removal of patients with at least one of the following characteristics: Patients with previous history of gastrointestinal surgery, patients with gastrointestinal malignancies, patients with gastrointestinal bleeding, Pregnant patients, patients with history of gastrointestinal caustic substance (acid -base), diabetic patients, patients with asthma or history of allergies. Then patients are randomly grouped into 4 discrete groups: Group A (control): 100 cc of plain warm water 20 minutes before endoscopy; Group B: 100 mg of Dimethicone in 100 cc of warm water 20 minutes before endoscopy; Group C: 600 mg of N- acetyl cysteine in 100 cc of warm water 20 minutes before endoscopy; Group D: 100 mg of Dimethicone and 600 mg of N- acetyl cysteine in 100 cc of warm water 20 minutes before endoscopy. Then Mucosal visibility in four discrete part of stomach would be checked by a fixed endoscopist and scoring, based on a specific scoring system, would be done.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903314226N1
Registration date: 2010-07-23, 1389/05/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-07-23, 1389/05/01
Registrant information
Name
Gholam Reza Sivandzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4316
Email address
ghsivand@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellery of research affairs in Shiraz University of Medical Sciences (as a thesis)
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2010-09-06, 1389/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of premedication with Dimethicone and N-acetyl cysteine for improving visibility during upper endoscopy
Public title
Effectiveness of Dimethicone and N-acetyl cysteine in improving stomach mucosal visibility
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: all patients referred to endoscopy centers, Motahari clinics and Faghihi hospital in shiraz, Iran, after obtaining informed consent. Exclusion criteria: Patients with previous history of gastrointestinal surgery, patients with gastrointestinal malignancies, patients with gastrointestinal bleeding, Pregnant patients, patients with a history of digestive caustic substance (acid -base), diabetic patients, patients with asthma or allergy.
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Near to Namazi Square, Zand St.
City
Shiraz
Postal code
Approval date
2010-06-01, 1389/03/11
Ethics committee reference number
CT-88-5072

Health conditions studied

1

Description of health condition studied
upper endoscopy
ICD-10 code
K20-K31
ICD-10 code description
Diseases of oesophagus, stomach and duodenum

Primary outcomes

1

Description
Amount of air bubbles and mucus present in four discrete regions of stomach
Timepoint
20 min after drug solution taking and during endoscopy
Method of measurement
lack of bubbles or amount of mucus and volumes of water needed to wash it away

Secondary outcomes

empty

Intervention groups

1

Description
Group A (control): 100 cc of plain warm water 20 minutes before endoscopy
Category
Placebo

2

Description
Group D: 100 mg of Dimethicone and 600 mg of N- acetyl cysteine in 100 cc of warm water 20 minutes before endoscopy
Category
Diagnosis

3

Description
Group B: 100 mg of Dimethicone in 100 cc of warm water 20 minutes before endoscopy
Category
Diagnosis

4

Description
Group C: 600 mg of N- acetyl cysteine in 100 cc of warm water 20 minutes before endoscopy
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari Clinic Endoscopy Center
Full name of responsible person
Dr Seyed Mohammad Kazem Hosseini Asl, Associate prof.
Street address
Second Floor of Motahari Clinic Building, Namazi Square
City
Shiraz

2

Recruitment center
Name of recruitment center
Faghihi Hospital Endoscopy Center
Full name of responsible person
Dr Seyed Mohammad Kazem Hosseini Asl, Associate prof.
Street address
Faghihi Hospital, After Setad square, Zand Avenue
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellery of research affairs in Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossein Dabaghmanesh
Street address
Seventh Floor, Central Building of Shiraz University of Medical Sciences, next to the Red Crescent, Zand Avenue
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery of research affairs in Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Gholam Reza Sivandzadeh
Position
Residency in Internal medicine
Other areas of specialty/work
Street address
Namazi Hospital, Bureau of Internal Medicine Ward
City
Shiraz
Postal code
Phone
+98 71 1647 4316
Fax
+98 71 1647 4316
Email
ghsivand@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohammad Kazem Hosseini Asl
Position
Faculty member, Associate Professor, Department of Internal Medicine, Specialty of Gastroenterology
Other areas of specialty/work
Street address
Namazi Hospital, Bureau of Internal Medicine Ward
City
Shiraz
Postal code
Phone
+98 71 1647 4316
Fax
+98 71 1647 4316
Email
hosseiniasl@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohammad Kazem Hosseini Asl
Position
Faculty member, Associate Professor
Other areas of specialty/work
Street address
Namazi Hospital, Bureau of Internal Medicine Ward
City
Shiraz
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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