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IRCT20120215009014N265 IRCT 2019-03-05 Hamedan University of Medical Sciences Comparison of the effect of intravenous nitroglycerine versus placebo the hemodynamic responses in patients undergo elective non-cardiac surgery Comparison of the effect of intravenous nitroglycerine versus placebo the hemodynamic responses in patients undergo elective non-cardiac surgery: a double blind randomized clinical trial 2018-08-23 anticipated 78 Complete https://irct.ir/trial/37536 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: 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, on two sheets the name of the intervention 2 and on the other 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 and placebos 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. Therefore, the trial will be run as double-blind. N/A Condition 1: blood pressure. Condition 2: heart rate. Intervention 1: Intervention group 1: Intravenous nitroglycerine 1 mic g/kg as single-dose before surgery. Intervention 2: Intervention group 2: Intravenous nitroglycerine 2 mic g/kg as single-dose before surgery. Intervention 3: Control group: Intravenous normal saline 5 ml as single-dose before surgery. 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 approval of the financial supporting organization.
public Shabnaz Sharifi
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 Shabnaz.sharifi@gmail.com Hamedan University of Medical Sciences scientific Dr. Pooran Hajian
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 pooranhajian567@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 65 years; Candidate for elective non-cardiac surgery; Weight less than 100 kg 18 years 65 years Both Using anti-hypertensive or anti-depressive drugs; Hyperthyroidism or hypothyroidism; Diabetes, renal failure, heart failure, or liver disorder; A history of myocardial infarction; Hypotension; Bradycardia R03.0 O76 Elevated blood-pressure reading, without diagnosis of hypertension Abnormality in fetal heart rate and rhythm complicating labor and delivery Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Intravenous nitroglycerine 1 mic g/kg as single-dose before surgery Intervention group 2: Intravenous nitroglycerine 2 mic g/kg as single-dose before surgery Control group: Intravenous normal saline 5 ml as single-dose before surgery Measuring systolic blood pressure. Timepoint: Before and 1, 3, 5 and 10 minutes after intubation. Method of measurement: Using sphygmomanometer. Measuring diastolic blood pressure. Timepoint: Before and 1, 3, 5 and 10 minutes after intubation. Method of measurement: Using sphygmomanometer. Measuring heart rates. Timepoint: Before and 1, 3, 5 and 10 minutes after intubation. Method of measurement: Using monitor machine. Hamedan University of Medical Sciences Approved 2018-08-20 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)