Comparison of acute and late reactions and patientʼs discomfort caused the injection of the iohxoll(omnipaque) and iodixanol(visipaque) in patients referred in the Golestan and Aria hodpitalʼs CTscan center in ahvaz in 2018
Which medication is easier for patients to take and has fewer side effects
Design
The study groups consisted of those who were using the first group of iohexol and the second group using iodoscapol. The sample size was 120 in each group.
Settings and conduct
The study was conducted in two hospitals of Golestan and Ariya in Ahvaz city and at the CT scan center. The method was done in such a way that patients with CT scan were injected with questions about post-injection complications.
Participants/Inclusion and exclusion criteria
Participants must be sober and awake .And to be able to respond to questions.Children less than seven years and People anesthetized Are excluded
Intervention groups
In the iohxoll group, the drug was injected according to the type of disease and weight of the patient.in the iodixanol group, the drug was injected according to the type of disease and weight of the patient
Main outcome variables
Feeling the heat.Feeling the pain.feeling the Nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161206031269N3
Registration date:2019-01-06, 1397/10/16
Registration timing:retrospective
Last update:2019-01-06, 1397/10/16
Update count:0
Registration date
2019-01-06, 1397/10/16
Registrant information
Name
Azin Khalafiniya
Name of organization / entity
Jundishapur University of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 61 4253 3449
Email address
khalafiniya.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-11, 1397/04/20
Expected recruitment end date
2018-10-12, 1397/07/20
Actual recruitment start date
2018-07-11, 1397/04/20
Actual recruitment end date
2018-10-12, 1397/07/20
Trial completion date
2018-10-12, 1397/07/20
Scientific title
Comparison of acute and late reactions and patientʼs discomfort caused the injection of the iohxoll(omnipaque) and iodixanol(visipaque) in patients referred in the Golestan and Aria hodpitalʼs CTscan center in ahvaz in 2018
Public title
Comparison of acute and late reactions and patientʼs discomfort caused the injection of the iohxoll(omnipaque) and iodixanol(visipaque)
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
The patient should be alert and awake
Able to talk
Exclusion criteria:
The patient has a CT scan without injections
Age
From 7 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
240
Actual sample size reached:
240
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
To reduce the possibility of information bias Which group of patients that belong .Uninformed Were kept
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committed of Ahvaz Jundishapour of Medical Sciences
Street address
Gileston st. , Jundishapour University of Medical Sciences, vice chancellor for Research and Technology
City
AHVAZ
Province
Khouzestan
Postal code
15794-61357
Approval date
2018-03-11, 1396/12/20
Ethics committee reference number
IRAJUMS.REC.1396.816
Health conditions studied
1
Description of health condition studied
Comparison of side effects of contrast agents and their severity in CT scan
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Do patients with drug injections after experiencing the warmth and nausea are hives
Timepoint
A few minutes after injection of the medication and conducting CT scans
Method of measurement
Questionnaire based on their side effects and severity
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention:The drug iohxoll 300 mg Was used That dose of On the basis of The patient's weight and the type of CT scan Specify and iv injection
Category
Treatment - Drugs
2
Description
TheThe second intervention:The drug iodixanol 320 mg Was used That dose of On the basis of The patient's weight and the type of CT scan Specify and iv injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr. Mojgan Samezadeh
Street address
Esfand Street
City
AHVAZ
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3374 3004
Email
sametzadeh.md@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hatam Boustani
Street address
golestan Ave.
City
AHVAZ
Province
Khouzestan
Postal code
39345-61355
Phone
+98 61 3333 7077
Email
info@ajums.ac.ir
Grant name
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
Private
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
Dr. Mojgan Samezadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Golestan Golestan Hospital, Ahvaz, Iran
City
AHVAZ
Province
Khouzestan
Postal code
39345-61355
Phone
+98 61 3333 7077
Email
sametzadeh.md@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Samezadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Golestan Ave. Golestan Hospital, Ahvaz Hospital
City
AHVAZ
Province
Khouzestan
Postal code
39345-61355
Phone
+98 61 3333 7077
Email
sametzadeh.md@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Samezadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Golestan Ave. Golestan Hospital, Ahvaz Hospital
City
AHVAZ
Province
Khouzestan
Postal code
39345-61355
Phone
+98 61 3333 7077
Email
sametzadeh.md@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only side effects can be shared
When the data will become available and for how long
2019
To whom data/document is available
Doctors and experts in Radiology
Under which criteria data/document could be used
For more research
From where data/document is obtainable
What processes are involved for a request to access data/document