Comparison of sedative effect of propofol_ketamine and propofol_fentanyl in patients undergoing gastrointestinal endoscopy procedure in ahvaz emam Khomeini hospital in 1399
Comparison of sedative effect of propofol ketamine and propofol fentanyl in patients undergoing endoscopy in Imam Khomeini Hospital, Ahvaz
Design
Clinical trial, phase 3 with parallel, randomized, double-blind groups
Settings and conduct
86 patients referred to the endoscopy ward of Imam Khomeini Hospital were randomly divided into two groups. Then, after obtaining their written consent, the first group was given 0.5 mg / kg propofol with 1 mg / kg ketamine and the second group 0.5 mg / kg propofol and 1 ųg/ kg fentanyl are injected and the sedation rate of these drugs is compared
Participants/Inclusion and exclusion criteria
In this study, which is performed on patients undergoing endoscopy in Imam Khomeini Hospital, all patients with an age range of 18 to 65 years will be studied, and patients with drug allergies, patients outside the age range of 18 to 65 years, patients with renal or liver failure. Other cardiovascular diseases and those who do not wish to participate in the study are excluded from the study
Intervention groups
Patients are divided into two groups and then the first group is given 0.5 mg / kg propofol with 1 mg / kg ketamine and the second group is injected with 0.5 mg / kg propofol and 1 g / kg fentanyl.
Main outcome variables
Sedation
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20200920048770N1
Registration date:2020-10-25, 1399/08/04
Registration timing:registered_while_recruiting
Last update:2020-10-25, 1399/08/04
Update count:0
Registration date
2020-10-25, 1399/08/04
Registrant information
Name
Fateme Jorfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 2462 3719
Email address
drjorfii2912@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sedative effect of propofol_ketamine and propofol_fentanyl in patients undergoing gastrointestinal endoscopy procedure in ahvaz emam Khomeini hospital in 1399
Public title
Comparison of sedative effect of propofol_ketamine and propofol_fentanyl in endoscopy procedure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients aged 18 to 65 years who have referred to Imam Khomeini Hospital in Ahvaz for endoscopic procedure
Exclusion criteria:
Patients under 18 or over 65 years of age
The patient's unwillingness to participate in the study
Patients contraindicated in propofol ketamine or propofol fentanyl
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind both sides, the study of the patient's degree of sedation according to the modified Ramsey criterion during the procedure was recorded by another person who did not know the prescribed drugs to the patient
Placebo
Not used
Assignment
Parallel
Other design features
Don't have
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Ahvaz Golestan Blvd. Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2020-09-02, 1399/06/12
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.045
Health conditions studied
1
Description of health condition studied
Sedation in patients undergoing endoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sedation
Timepoint
Before and during the intervention
Method of measurement
Ramsay sedation scale
Secondary outcomes
1
Description
Pain
Timepoint
Before and during the intervention
Method of measurement
Ambesh scor
2
Description
nausea
Timepoint
After the end of the intervention until the exit from recovery
Method of measurement
According to the visual analog scale ( vas )on a ruler that is scaled from zero to ten, zero is equivalent to nausea and ten is equivalent to maximum nausea.
3
Description
Vomiting
Timepoint
After the end of the intervention until the exit from recovery
Method of measurement
Count the number of vomits
Intervention groups
1
Description
Intervethe group: first intervention group was injected with 0.5 mg / kg propofol made by Donk Kong South Node along with 1 mg / kg ketamine made by Trittau, Italy before the intervention
Category
Treatment - Drugs
2
Description
Intervention group: The second intervention group was injected with 0.5 mg / kg propofol made by donk kòng company of South Korea in one dose with 1Ųg / kg fentanyl made by Caspian Iran company before the intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endoscopy ward of Imam Khomeini Hospital in Ahvaz
Full name of responsible person
Reza Akhondzade
Street address
Ahvaz St., Azadegan St., Imam Khomeini Medical Center, Endoscopy Department
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 9166
Email
Rezaakh@hotmail.com
Web page address
Https://himam.ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Golestan Boulevard. Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 3815
Email
Mail@Ajums.ac.ir
Web page address
Http://Journals.ajums.ac.ir/jjhs
Grant name
Three million and five hundred thousand rials
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fateme Jorfi
Position
General Medicine Intern
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz, Mehr St., between Dey and Azar, Shahid Rajaei dormitory
City
Ahvaz
Province
Khouzestan
Postal code
6135853415
Phone
+98 61 3320 5459
Email
Drjorfii2912@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Akhondzade
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz, Azadegan St., Imam Khomeini Educational and Medical Center
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 9166
Email
Rezaakh@hotmail.com
Web page address
Https://himam.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fateme Jorfi
Position
Medical lntern
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz, Mehr Street, Between Dey and Azar Street, Shahid Rajaei Dormitory
City
Ahvaz
Province
Khouzestan
Postal code
6135853415
Phone
+98 61 3320 5459
Email
Drjorfii2912@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Patients referred for endoscopy in Imam Khomeini Hospital were randomly divided into two groups and by injecting propofol ketamine to one group and injecting propofol fentanyl to the other group, the sedation rate of this drugs was compared.
When the data will become available and for how long
The access period will start after the end of the work and the results will be registered
To whom data/document is available
It will be accessible to everyone
Under which criteria data/document could be used
To access this data, the keywords sedative, propofol ketamine, propofol fentanyl and endoscopy are used
From where data/document is obtainable
Request an email to rezaakh@hotmail.com
What processes are involved for a request to access data/document
The request should be sent to the email of the person in charge of the study