Clinical trial of comparing the physician’s satisfaction of adequacy of sedation for endoscopy in two groups of patients whose type of sedation will be chosen by the doctor or by the patient
The aim of this study is to compare the physician’s satisfaction of adequacy of sedation for endoscopy in two groups of patients whose type of sedation will be chosen by the doctor or by the patient.
Accordingly, one hundred and forty adult patients who do not have any severe systemic disease and are refered to Imam Khomeini Hospital of Sari for diagnostic upper gastrointestinal endoscopy will be randomly assigned into two groups in order to compare the adequacy of upper GI tract endoscopy after choosing the type of sedation by either the physician or by the patient who were provided by educational pamphlets, stating the different kinds of sedation and their probable adverse effects.
Finally, the satisfaction of the physician about the adequacy of sedation for completing the procedure of endoscopy will be analyzed and compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606062499N4
Registration date:2016-11-30, 1395/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-30, 1395/09/10
Registrant information
Name
Hafez Tirgar Fakheri
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 1700
Email address
hfakheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Mazandaran University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2017-01-21, 1395/11/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparing the physician’s satisfaction of adequacy of sedation for endoscopy in two groups of patients whose type of sedation will be chosen by the doctor or by the patient
Public title
The Physician’s Satisfaction of the Quality of Endoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: the need for diagnostic upper gastrointestinal endoscopy
Exclusion criteria: age below 18 or above 80 years; severe cardiopulmonary, renal or liver failure
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients were divided by blocked randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Etics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square, Sari, Mazandaran, Iran
City
Sari
Postal code
Approval date
2014-05-29, 1393/03/08
Ethics committee reference number
H-92-33
Health conditions studied
1
Description of health condition studied
Diseases of upper digestive system which need endoscopy
ICD-10 code
K20
ICD-10 code description
Oesophagitis
2
Description of health condition studied
Diseases of upper digestive system which need endoscopy
ICD-10 code
K25
ICD-10 code description
Gastric ulcer
3
Description of health condition studied
Diseases of upper digestive system which need endoscopy
ICD-10 code
K22.7
ICD-10 code description
Barrett oesophagus
Primary outcomes
1
Description
physician's satisfaction of the adequacy of sedation for performing endoscopy
Timepoint
Immediately after completing the endoscopy
Method of measurement
questionnaire
Secondary outcomes
1
Description
Quality of endoscopy
Timepoint
during and 20 ئهدعفثس after the endoscopy
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group:
The type of sedation (including intravenous Midazolam 1.5 milligram, intravenous Pethidine 12.5 milligram or general anesthesia) will be chosen by the patient after being educated by a pamphlet.
Category
Treatment - Drugs
2
Description
Control group 1:
In this group, Intravenous Midazolam 1.5 milligram will be injected to the patient before performing endoscopy. The dose and/ or type of sedative may change during endoscopy according to the physician's opinion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Hafez Fakheri
Street address
Imam Khomeini Hospital, Amir Mazandarani street, Sari, Mazandaran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ahmad Ali Enayati
Street address
Mazandaran University of Medical Sciences, Moallem Square, Sari, Mazandaran
City
Sari
Grant name
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Hafez Fakheri
Position
Professor; Gastroenterologist
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Sari
Postal code
4816633131
Phone
+1 133361700
Fax
Email
hafezfakheri@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hafez Fakheri
Position
Professor/ Gastroenterologist
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Amir Mazandarani Street, Sari, Mazandaran
City
Sari
Postal code
48166 33131
Phone
+1 133361700
Fax
Email
hafezfakheri@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hafez Fakheri
Position
Professor; Gastroenterologist
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Amir Mazandarani Street, Sari, Mazandaran
City
Sari
Postal code
48166 33131
Phone
+1 133350670
Fax
Email
hafezfakheri@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)