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IRCT20120215009014N391 IRCT 2021-04-23 Hamedan University of Medical Sciences Comparison of the effect of three medications on clinical symptoms of patients undergoing open heart surgery Comparison of the effect of midazolam, etomidate and propofol on hemodynamic changes in patients undergoing coronary artery bypass graft surgery: a double -blind randomized clinical trial 2021-05-22 anticipated 90 Complete https://irct.ir/trial/55633 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on two sheets the name of the intervention 1 and on two other sheets the name of the intervention 2 and on the third two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: The shape of the medications will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind. 3 Coronary artery bypass graft surgery. Intervention 1: Intervention group 1: Intravenous infusion of midazolam (manufactured by Oxir Pharmaceutical Co.) 0.15 mg/kg single dose before anesthesia. Intervention 2: Intervention group 2: Intravenous infusion of etomidate (manufactured by Abureihan Pharmaceutical Co.) 0.2 mg/kg single dose before anesthesia. Intervention 3: Intervention group 3: Intravenous infusion of propofol (manufactured by Tehran Shimi Pharmaceutical Co.) 1.5 mg/kg single dose before anesthesia. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situations and the results of the study as well as the approval of the financial supporting organization.
public Parsa Afghanian
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 parsaafn@yahoo.com Hamedan University of Medical Sciences scientific Dr. Ahamad Reza Salimi Bahrami
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 salimbahrami@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 40 to 70 years, Candidate for coronary artery bypass graft surgery, 40 years 70 years Both Diabetes, Requires emergency coronary artery bypass graft surgery I25.709 Atherosclerosis of coronary artery bypass graft(s), unspecified, with unspecified angina pectoris Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Intravenous infusion of midazolam (manufactured by Oxir Pharmaceutical Co.) 0.15 mg/kg single dose before anesthesia Intervention group 2: Intravenous infusion of etomidate (manufactured by Abureihan Pharmaceutical Co.) 0.2 mg/kg single dose before anesthesia Intervention group 3: Intravenous infusion of propofol (manufactured by Tehran Shimi Pharmaceutical Co.) 1.5 mg/kg single dose before anesthesia Heart rate. Timepoint: One minute before induction of anesthesia and at 1, 2, 5 and 10 minutes after intubation. Method of measurement: Using monitoring machine. Systolic blood pressure. Timepoint: One minute before induction of anesthesia and at 1, 2, 5 and 10 minutes after intubation. Method of measurement: Using monitoring machine. Mean arterial blood pressure. Timepoint: One minute before induction of anesthesia and at 1, 2, 5 and 10 minutes after intubation. Method of measurement: Using monitoring machine. Electrocardiographic changes. Timepoint: One minute before induction of anesthesia and at 1, 2, 5 and 10 minutes after intubation. Method of measurement: Using monitoring machine. Diastolic blood pressure. Timepoint: One minute before induction of anesthesia and at 1, 2, 5 and 10 minutes after intubation. Method of measurement: Using monitoring machine. Hamedan University of Medical Sciences Approved 2021-04-10 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)