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IRCT20141009019470N109 IRCT 2021-02-08 Shiraz University of Medical Sciences The Efficacy of Tranexamic Acid and the Association of Rate Pressure Product Index on Intraoperative Bleeding during Rhinoplasty. The Efficacy of Tranexamic Acid and the Association of Rate Pressure Product Index on Intraoperative Bleeding during Rhinoplasty. 2021-02-17 anticipated 86 Complete https://irct.ir/trial/53712 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Computer-generated randomization table will be used to randomly allocated patients to the intervention and placebo groups based on www.sealedenvelope.com Seed: 258004702634303 block sizes 4,6 and 8, Blinding description: Medications were prepared by other nurses who were totally unaware of the nature of the study. While anesthesiologist and surgeon were blinded, Neither the participants nor the investigators involved in data collection and assessing the outcomes are aware of the identity of the target drugs used in the study. 2-3 Rhinoplasty surgery. Intervention 1: Intervention group: patients received 1gr Tranexamic acid intraoperatively (total volume of 10 cc). Intervention 2: Control group: patients received the same volume of Tranexamic acid (10 cc) of normal saline as placebo intraoperatively in the second group. No - There is not a plan to make this available Justification or reason for not sharing IPD is Its against our center polices.
public Forogh Moradi
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 forooghmoradi.fm.67@gmail.com Shiraz University of Medical Sciences scientific Mehrdad Salari
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 msalari@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 18-45 year_ old patients undergoing rhinoplasty surgery. 18 years 45 years Both Patients with systemic disease History of any drug consumption Hemorrhagic disease Liver dysfunction Renal dysfunction Using anticoagulant drugs Heart block Myocardial ischemia Morbid obesity Z41.1 Encounter for cosmetic surgery Prevention Placebo Intervention group: patients received 1gr Tranexamic acid intraoperatively (total volume of 10 cc) Control group: patients received the same volume of Tranexamic acid (10 cc) of normal saline as placebo intraoperatively in the second group. Intra and postoperative bleeding. Timepoint: Intra-operatively. Method of measurement: Weighing surgical gauzes using a digital scale. The rate-pressure product (RPP). Timepoint: Every 10 min. Method of measurement: Formula: heart rate multiply systolic arterial pressure. Blood pressure. Timepoint: In the recovery room for the first 6. Method of measurement: Noninvasive blood pressure monitoring. Shiraz University of Medical Sciences Approved 2019-01-13 Ethics committee of Shiraz University of Medical Sciences Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)