Comparative study of intravenous injection of methadone and sufentanil on hemorrhage in patients with opioid addiction under cardiopulmonary bypass surgery
Comparative study of intravenous injection of methadone and sufentanil on hemorrhage in patients with opioid addiction under cardiopulmonary bypass surgery
Design
This study is a double-blinded clinical trial. The study population will included all patients undergoing bypass surgery who will refer to the Imam Ali hospital in Kermanshah city. A total of 159 eligible patients will be selected conveniently and randomly assigned to three groups (two intervention and one control group)
Settings and conduct
This study, which will be done at Imam Ali hospital of Kermanshah city is double-blinded , that patients and researchers are unaware of the study groups, the type of drug and the dose of the drug. At the beginning of the study, the rate of bleeding in each of the three groups is recorded in a checklist
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with opioid addiction; Patients undergoing bypass surgery
Exclusion criteria: Having any history of coagulation disorder; Systolic blood pressure above 160 and less than 100; Renal failure patients
Intervention groups
The first intervention group will receive 0.5 mg/kg of methadone at a dose of 0.5-2 mg, during and after surgery in
ICU. The second intervention group will receive 3 μg of sufentanil at a dose of 5-10 μg during and after surgery in ICU. The control group will receive 0.5 mg of placebo
Main outcome variables
The rate of bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N103
Registration date:2018-10-06, 1397/07/14
Registration timing:registered_while_recruiting
Last update:2018-10-06, 1397/07/14
Update count:0
Registration date
2018-10-06, 1397/07/14
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-16, 1397/06/25
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of intravenous injection of methadone and sufentanil on hemorrhage in patients with opioid addiction under cardiopulmonary bypass surgery
Public title
Comparison of intravenous injection of methadone and sufentanil on hemorrhage in patients with opioid addiction under cardiac surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with opioid addiction
Patients undergoing bypass surgery
Exclusion criteria:
Having any history of coagulation disorder
Systolic blood pressure above 160 and less than 100
Renal failure patients
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
159
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients and the investigator will kept blinded to the study groups, the type of drug and the dose of the drug
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-09-11, 1397/06/20
Ethics committee reference number
ir.kums.rec.1397.418
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
The rate of bleeding
Timepoint
During the operation and in the I.C.U
Method of measurement
Based on observation doctor
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive 0.5 mg/kg of methadone at a dose of 0.5-2 mg, during and after surgery in ICU
Category
Treatment - Drugs
2
Description
. The second intervention group will receive 3 μg of sufentanil at a dose of 5-10 μg during and after surgery in ICU
Category
Treatment - Drugs
3
Description
The control group will receive 0.5 mg of placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali Hospital
Full name of responsible person
Fatemeh Rangani
Street address
Imam Ali Hospital, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0041
Email
shimarangani@YAHOO.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Rangani
Position
Residents anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Ali Hospital, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0041
Email
shimarangani@YAHOO.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Moradi
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Ali Hospital, Shahid Beheshti Blvd.
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0041
Email
Drmoradi2008@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Rangani
Position
Residents anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Ali Hospital, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0041
Email
shimarangani@YAHOO.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
2months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
En In a 30-day period, the documents will be sent e-mail