Investigating the effect of dexmedetomidine drug infusion on hemodynamic changes and sedation after coronary bypass surgery (CABG)in opuim addict patients
The purpose of this study is to investigate the effect of dexmedetomidine drug infusion on hemodynamic changes and sedation after coronary artery bypass surgery in opium addicted patients.
Design
Clinical trial with 3 groups, with factorial groups (including groups: a- dexmedetomidine with a dose of 0.2 µg/kg/h, b- normal saline with a dose of 0.2 µg/kg/h), double blind, randomized, phase 2 on 112 patients. People are assigned to two groups using a lottery.
Settings and conduct
Place: Heart ICU of Shafa Kerman Hospital, drugs will be given in the form of infusion. Due to the unconsciousness of the patient, one side will be blind by itself. The treatment regimen is also given by the nurse, and therefore, the researcher for analyzing sedation and hemodynamics and the person analyzer of the data will also be unaware of the treatment protocol. Therefore, the three strains are considered blind.
Participants/Inclusion and exclusion criteria
Clinical trial with 2 groups, with factorial groups (including groups: a- dexmedetomidine with a dose of 0.2 µg/kg/h, b- normal saline with a dose of 0.2 µg/kg/h), three-blind, randomized, phase 2 on 112 patients.
Intervention groups
A- Dexmedetomidine with a dose of 0.2 µg/kg/h
B- normal saline with a dose of 0.2 µg/kg/h (control)
Main outcome variables
Hemodynamic changes, sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230825059256N1
Registration date:2023-09-07, 1402/06/16
Registration timing:prospective
Last update:2023-09-07, 1402/06/16
Update count:0
Registration date
2023-09-07, 1402/06/16
Registrant information
Name
Arsalan Eskandari Damaneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3214 1461
Email address
arsalaneskandaridamaneh55@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of dexmedetomidine drug infusion on hemodynamic changes and sedation after coronary bypass surgery (CABG)in opuim addict patients
Public title
Investigating the effect of dexmedetomidine drug administration on hemodynamic changes and sedation after heart surgery in opium addicted patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Drug addiction (opium, methadone and syrup) based on DSM-V criteria
Patients undergoing on-pump heart surgery
Stable hemodynamics
Patients without cardiac pacemaker
Absence of liver and kidney disorders
Patients willing to participate in the study
Exclusion criteria:
Bradycardia with a rate less than 60 beats per minute
Unstable hemodynamics
People who need high-dose vasoconstrictor drugs
profuse bleeding
Disagreement to continue cooperation in the study by the first degree companions
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, randomization by lottery, first, the number of samples A and B is written on paper and placed in a bag. After each patient's visit, a sheet from the selection bag and the type of treatment intervention written is assigned to that patient. This is done as many times as necessary for the selection sample.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is conducted in a triple blind manner, the patient and the person who measures the final outcome and the statistical analysis do not know which group is the intervention group and receives the drug dexmedetomidine, and only the nurse of each patient knows about the patient receiving dexmedetomidine, and the control group receives normal saline infusion. And the person responsible for data registration has no knowledge, and web forms are registered as A.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Afzalipur Medical Education Center of Kerman University of Medical Scie
Street address
Afzalipur Medical Education Center, Imam Khomeini Highway (RA),Kerman,Iran,
City
Kerman
Province
Kerman
Postal code
7616913911
Approval date
2023-08-13, 1402/05/22
Ethics committee reference number
IR.KMU.AH.REC.1402.087
Health conditions studied
1
Description of health condition studied
Coronary artery bypass surgery
ICD-10 code
I25.0
ICD-10 code description
Atherosclerotic cardiovascular disease, so described
2
Description of health condition studied
addiction to opiod
ICD-10 code
F11.1
ICD-10 code description
Opioid abuse
Primary outcomes
1
Description
Hemodynamic changes
Timepoint
At the beginning, 3, 6, 8 and 12 hours after the operation
Method of measurement
Monitoring device
2
Description
relaxation
Timepoint
At the beginning, 3, 6, 8 and 12 hours after the operation
Control group: receiving normal saline 0.2 µg/kg/h
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Hossein Sadeghi Gogheri
Street address
Shafa Medical Education Center,Kausar Blvd., Kerman,Iran
City
Kerman
Province
Kerman
Postal code
76187751151
Phone
+98 34 3211 5780
Email
shafahospital@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Research and technology department, at the beginning of Ibn Sina street, Somayeh Crossroads(Tahmasababad), Kerman
City
kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
KMU_RESEARCH@YAHOO.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Arsalan Eskandari Damaneh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No.17, Alley 13, Hezar Blvd. Tehran road, Kerman
City
Kerman
Province
Kerman
Postal code
7617919811
Phone
+98 34 3214 1461
Fax
Email
arsalaneskandaridamaneh55@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahdieh Sharifzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kerman, Shafa Street, Shafa Hospital
City
kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
msharifzade78@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Arsalan Eskandari Damaneh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No.17, Alley 13, Hezar Blvd. Tehran road, Kerman
City
Kerman
Province
Kerman
Postal code
7617919811
Phone
+98 34 3214 1461
Fax
Email
arsalaneskandaridamaneh55@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
At the end of the study, part of the information including the effect of dexmedetomidine drug infusion on hemodynamic changes and sedation after coronary artery bypass surgery in opium addicted patients, after deidentifying the individuals, will be shared with those interested in the health field.
When the data will become available and for how long
2 to 6 months after data analysis
To whom data/document is available
Health researchers
Under which criteria data/document could be used
In order to use the results and during the written request
From where data/document is obtainable
Arsalan Eskandari- Email
What processes are involved for a request to access data/document