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IRCT20230825059256N1 IRCT 2023-09-07 Kerman University of Medical Sciences Investigating the effect of dexmedetomidine drug administration on hemodynamic changes and sedation after heart surgery in opium addicted patients Investigating the effect of dexmedetomidine drug infusion on hemodynamic changes and sedation after coronary bypass surgery (CABG)in opuim addict patients 2023-09-23 anticipated 112 Complete https://irct.ir/trial/72282 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Condition 1: Coronary artery bypass surgery. Condition 2: addiction to opiod. Intervention 1: Intervention group: receiving dexmedtomidinmin 0.2 µg/kg/h. Intervention 2: Control group: receiving normal saline 0.2 µg/kg/h. Yes - There is a plan to make this available What will be shared: 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: 2 to 6 months after data analysis To whom: Health researchers Conditions: In order to use the results and during the written request Where to obtain: Arsalan Eskandari- Email How to obtain: The purpose of accessing data - requesting e-mail Comments:
public Arsalan Eskandari Damaneh
No.17, Alley 13, Hezar Blvd. Tehran road, Kerman
Kerman Iran (Islamic Republic of) 7617919811 +98 34 3214 1461 arsalaneskandaridamaneh55@gmail.com Kerman University of Medical Sciences scientific Mahdieh Sharifzadeh
Kerman, Shafa Street, Shafa Hospital
kerman Iran (Islamic Republic of) 7618751151 +98 34 3211 5780 msharifzade78@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) 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 18 years 80 years Both 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 I25.0 F11.1 Atherosclerotic cardiovascular disease, so described Opioid abuse Treatment - Drugs Placebo Intervention group: receiving dexmedtomidinmin 0.2 µg/kg/h Control group: receiving normal saline 0.2 µg/kg/h Hemodynamic changes. Timepoint: At the beginning, 3, 6, 8 and 12 hours after the operation. Method of measurement: Monitoring device. Relaxation. Timepoint: At the beginning, 3, 6, 8 and 12 hours after the operation. Method of measurement: modified Ramsay scores. Kerman University of Medical Sciences Approved 2023-08-13 Research Ethics Committee of Afzalipur Medical Education Center of Kerman University of Medical Scie Afzalipur Medical Education Center, Imam Khomeini Highway (RA),Kerman,Iran, Kerman Kerman Iran (Islamic Republic of)