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IRCT20151012024493N5 IRCT 2023-02-17 Shahid Beheshti University of Medical Sciences Comparison of clonidine and tranexamic acid on the control of lumbar surgical bleeding Comparison of the effect of oral clonidine and intravenous Tranexamic acid on bleeding control in posterior lumbar spine fusion surgery 2023-03-06 anticipated 136 Complete https://irct.ir/trial/66512 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, people enter the study groups by lottery; In such a way that the type of injectable drug used is placed in the desired number in the sealed opaque envelopes that are coded. Each of the codes is also written on a piece of paper, folded and placed inside a box. After entering the operating room, each patient takes out one of the pieces of paper from the box. The envelope has the same number as the number inside the selected paper. which is applied to the patient. This work continues until the end of the papers so that the number of patients reaches the desired number in the groups, Blinding description: Medicines will be prescribed by the first researcher. The second researcher will record and evaluate the results and they will be unaware of the type of drug injected by the first researcher; Also, the coded information collection form will also be delivered to the statistical consultant; In the information collection forms, the type of medicine is not clear. 2-3 Bleeding. Intervention 1: Intervention group 1: 30 minutes before surgery, this group will be given an oral clonidine tablet of 0.2 mg to drink with 50 ml of water. This pill will be given to the patient only once; The drug used will be purchased from Abidi Pharmaceuticals. Intervention 2: Intervention group 2: This group will be given the drug tranexamic acid 10 mg per kilogram and after the start of the surgery in the form of infusion. This medicine will be prepared as an infusion (20 mg in a 50 ml syringe), the infusion rate will be 10 ml per hour. The drug used will be purchased from Abidi Pharmaceuticals. 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 The obtained data will be analyzed and published in the form of thesis and article.
public Parisa Sezari
Loghman Hakim hospital, Makhsus St., South Kargar Ave., Tehran
Tehran Iran (Islamic Republic of) 1333631151 +98 21 5542 4040 parissasezari@yahoo.com Shahid Beheshti University of Medical Sciences scientific Parisa Sezari
Loghman Hakim hospital, Makhsus St., South Kargar Ave., Tehran
Tehran Iran (Islamic Republic of) 1333631151 +98 21 5542 4040 parissasezari@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) American Society of Anesthesiology (ASA) physical class I and II Candidate for posterior lumbar spine fusion surgery Patient satisfaction Age 18-50 years 18 years 50 years Both Hemoglobin less than 10 Having hemophilia G97.32 Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating other procedure Prevention Prevention Intervention group 1: 30 minutes before surgery, this group will be given an oral clonidine tablet of 0.2 mg to drink with 50 ml of water. This pill will be given to the patient only once; The drug used will be purchased from Abidi Pharmaceuticals. Intervention group 2: This group will be given the drug tranexamic acid 10 mg per kilogram and after the start of the surgery in the form of infusion. This medicine will be prepared as an infusion (20 mg in a 50 ml syringe), the infusion rate will be 10 ml per hour. The drug used will be purchased from Abidi Pharmaceuticals. Bleeding. Timepoint: Record the amount of bleeding at the beginning of the surgery, at the end of the surgery and then every six hours for three days after the surgery. Method of measurement: Observing the amount of blood in surgical suction, gas and surgical lunggas, and blood observed in the surgical drain. Shahid Beheshti University of Medical Sciences Approved 2022-01-30 Ethics committee of Sِhahid Beheshti University of Medical Sciences Near Ayatollah Taleghani Hospital, Shahid Arabi St, Yemen St, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)