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IRCT20210415050976N11 IRCT 2022-05-05 Jahrom University of Medical Sciences Comparison of four drugs clonidine, bisoprolol, tranexamic acid and gabapentin on bleeding rate, hemodynamic stability and intraoperative surgeon satisfaction in patients undergoing rhinoplasty surgery. Comparison of four drugs clonidine, bisoprolol, tranexamic acid and gabapentin on bleeding rate, hemodynamic stability and intraoperative surgeon satisfaction in patients undergoing rhinoplasty surgery. 2022-05-10 anticipated 130 Complete https://irct.ir/trial/61261 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, computerized block randomization (13 blocks of 10) will be performed. An independent epidemiologist who is not involved in the study will use a random blockchain program (SATA 14) to generate allocation codes. Eligible participants, after signing the informed consent form, will be divided into five equal groups: clonidine, bisoprolol, gabapentin, tranexamic acid and placebo. Random sequences will be placed in light-resistant and sealed envelopes. The research assistant will open sealed, numbered, and opaque envelopes containing the assignment codes, Blinding description: For blinding in the present study, the double-blind method is used, so that 1- the person who reviews the results and 2- the person who performs the injections do not know which patient has received clonidine, bisoprolol, gabapentin, tranxamic acid and Placebo only.The drugs Clonidine, bisoprolol, gabapentin, tranexamic acid, and placebo will be packaged in identical glass( two groups of clonidine and bisoprolol, which are in the form of tablets, are powdered and then placed in capsules. The capsules will be the same in all 5 groups) and given to the prescriber, and will be placed in the drug or placebo group, according to a random list, and the glass will be marked A, B, C, D, E will be given to the patient and the patient will be unaware of the type of medicine used. 1-2 Rhinoplasty surgery. Intervention 1: Intervention group 1: They will receive clonidine 0/2 mg intravenously. Intervention 2: Intervention group 2: They will receive 5.2 mg bisoprolol tablets. Intervention 3: Intervention group 3: They will receive 4 capsules of gabapentin 300 mg . Intervention 4: Intervention group 4: They will receive 4 capsules of 250 mg tranexamic acid. Intervention 5: Control group: Placebo will normally receive intravenous saline. 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 There is no more information.
public Navid Kalani
Jahrom, Shahid Motahari Boulevard
Jahrom Iran (Islamic Republic of) 7167758256 +98 71 2536 5231 k.navid@jums.ac.ir Jahrom University of Medical Sciences scientific Navid Kalani
Jahrom, Shahid Motahari Blvd., University of Medical Sciences
Jahrom Iran (Islamic Republic of) 71542585125 +98 71 2536 5231 k.navid@jums.ac.ir Jahrom University of Medical Sciences Iran (Islamic Republic of) Hemoglobin above 10 Lack of sensitivity to the drugs used 18 years no limit Both Patients with coagulation disorders Blood pressure Coronary artery disease Rhinoplast Rhinoplasty surgery Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: They will receive clonidine 0/2 mg intravenously. Intervention group 2: They will receive 5.2 mg bisoprolol tablets. Intervention group 3: They will receive 4 capsules of gabapentin 300 mg . Intervention group 4: They will receive 4 capsules of 250 mg tranexamic acid. Control group: Placebo will normally receive intravenous saline. Blood preasure. Timepoint: Before induction، after induction، 1 minute after induction،5 minutes after induction، 30، 60، 90 and 120 minutes during operation، enter recovery and exit recovery. Method of measurement: Monitoring. Surgeon Satisfaction. Timepoint: During the operation every 15 minutes after the start of surgery and at the end of the operation. Method of measurement: Beozaart Scale. Bleeding. Timepoint: During the operation. Method of measurement: The amount of bleeding in the suction in milliliters. Relaxation. Timepoint: In recovery. Method of measurement: Ramsey sedation criteria. Jahrom University of Medical Sciences Approved 2022-01-11 Ethics Committee of Jahrom University of Medical Sciences Jahrom, Shahid Motahari Boulevard, Jahrom University of Medical Sciences, Vice Chancellor for Research Shiraz Fars Iran (Islamic Republic of)