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IRCT20171030037093N33 IRCT 2020-03-27 Esfahan University of Medical Sciences Comparison of the effect of two doses of tranexamic acid on hemodynamic changes in patients Comparative study of the effect of two doses of tranexamic acid on intraoperative hemodynamic changes in patients undergoing adenotonsillectomy 2020-04-03 anticipated 64 Complete https://irct.ir/trial/46553 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: The study sample was simple randomly divided into two groups of 32 people, each by selective envelopes. Thus, each envelope containing one of the two A and B labels represented one of the groups, Blinding description: The blinding method is that the drugs are drawn and coded by the researcher in equal volumes on the same syringes. The prescribing anesthetist and the nurse recorder are not aware of the patients' placement in the groups. 2 Hemodynamic changes. Intervention 1: Intervention group 1: First group receive 5mg / kg tranexamic acid from Caspian Pharmaceutical Company intravenously and slowly once during 10 minutes before surgery. Intervention 2: Intervention group 2: Second group receive 10 mg / kg tranexamic acid from Caspian Pharmaceutical Company intravenously and slowly once during 10 minutes 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 I will decide until finishing the study
public Amir Shafa
Imam Hussein Hospital
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3445 2031 amir_shafa@med.mui.ac.ir Esfahan University of Medical Sciences scientific Amir Shafa
Imam Hussein Hospital
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3445 2031 amir_shafa@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Children aged 5 to 10 years are candidates for ASAI, ASAI adenotonsillectomy. 5 years 10 years Both The patient has any underlying disease The patient has bleeding disorders Patient with coagulation disorders (PT, PTT, INR) The patient has metabolic disorders R03 Abnormal blood-pressure reading, without diagnosis Treatment - Drugs Treatment - Drugs Intervention group 1: First group receive 5mg / kg tranexamic acid from Caspian Pharmaceutical Company intravenously and slowly once during 10 minutes before surgery. Intervention group 2: Second group receive 10 mg / kg tranexamic acid from Caspian Pharmaceutical Company intravenously and slowly once during 10 minutes before surgery. Mean arterial pressure. Timepoint: Before induction and during anesthesia every 15 minutes. Method of measurement: Mercury barometer. Pulse rate. Timepoint: Before induction and during anesthesia every 15 minutes. Method of measurement: Pulse oximetry. Esfahan University of Medical Sciences Approved 2020-02-29 Ethics Committee of Isfahan University of Medical Sciences Isfahn University of Medical Sciences, Hezar jarib st, Isfahan Isfahan Isfehan Iran (Islamic Republic of)