]>
IRCT20120215009014N390 IRCT 2021-04-18 Hamedan University of Medical Sciences Effect of Dexmedetomidine versus Transaxamic acid on intraoperative bleeding during functional endoscopic sinus surgery Effect of Dexmedetomidine versus Transaxamic acid on intraoperative bleeding during functional endoscopic sinus surgery: a triple-blind randomized clinical trial 2021-04-21 anticipated 72 Complete https://irct.ir/trial/55620 interventional Randomization: Randomized, Blinding: Triple 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 four sheets of paper, writing on two sheets the name of the intervention 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 four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: The drugs will be given a code. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Thus, the trial will be run as triple-blind. 3 Chronic rhino sinusitis. Intervention 1: Intervention group 1: Transaxamic acid injection (manufactured by Caspian Pharmaceutical Co.) 11 mgr/kg by intravenous infusion within 15 minutes. Intervention 2: Intervention group 2:Dexmedetomidine injection (manufactured by Behestan Daru Pharmaceutical Co.) one micgr/kg by intravenous infusion within 15 minutes. 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 Dr Negar Ghaghi
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 negarhaghi27@yahoo.com Hamedan University of Medical Sciences scientific Dr. Mohammad Saeid Ahmadi
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 ahmadi@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 61 years, Chronic rhino sinusitis with or without polyposis, Candidate for functional endoscopic sinus surgery, 18 years 61 years Both Coagulopathy disorders, Taking anticoagulant medication in the last 5 days, History of thromboembolism, Acute or chronic renal failure, Hepatic cirrhosis, Uncontrolled chronic diseases such as hypertension, diabetes, heart failure, Having cardiac stent, Pregnancy J32 Chronic sinusitis Treatment - Drugs Treatment - Drugs Intervention group 1: Transaxamic acid injection (manufactured by Caspian Pharmaceutical Co.) 11 mgr/kg by intravenous infusion within 15 minutes Intervention group 2:Dexmedetomidine injection (manufactured by Behestan Daru Pharmaceutical Co.) one micgr/kg by intravenous infusion within 15 minutes Intraoperative bleeding volume. Timepoint: At 15, 30, 60 and 90 minutes after the start of surgery. Method of measurement: Using a calibrated suction chamber after reducing the volume of normal saline. Hemodynamic changes. Timepoint: At 15, 30, 60 and 90 minutes after the start of surgery. Method of measurement: Using monitoring machine. Hamedan University of Medical Sciences Approved 2020-06-13 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)