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IRCT20201205049602N1 IRCT 2021-04-24 Mazandaran University of Medical Sciences Comparison of the effect of tranexamic acid and phenylephrine on bleeding rate in rhinoplasty Comparative study of local effect of tranexamic acid and phenylephrine on bleeding rate in rhinoplasty 2020-12-06 anticipated 98 Complete https://irct.ir/trial/52757 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Individuals are assigned a login number in the order they enter. This number is also used for all their data collection forms. The randomization sequence is generated by an epidemiologist based on rendomizer software. Randomization is first divided into two categories based on the name of the surgeon (two surgeons). Then, in each of these two classes, randomization is performed in a one-to-one ratio in variable block sizes (multiples of 2). Based on this, people are assigned to one of the two groups studied. The numbers are based on the order in which people enter the study. From 1 to 98.These numbers are written on the back of the envelopes and inside the code envelope specified by the randomizer software. In order, after entering each person with the eligibility criteria, the first envelope is opened and based on the specified code, the drug with the same code written on the label is injected into the person. Website address of rendomizer software:https://www.randomizer.org/‏‏, Blinding description: The patient is anesthetized and is not aware of his affiliation with any of the study groups. Mesh preparation with phenylephrine and tranexamic acid content is performed by an independent colleague and the physician and the outcome assessor are not aware of the assignment of the subjects to the study groups. 3 Rhinoplasty. Intervention 1: Intervention group: In the first group, 1 cc of phenylephrine (Phenylephrine Hcl, Nasal Drop, 0.5%) is drawn with a syringe and poured on the mesh and packed for five minutes immediately after intubation and before making a surgical incision inside the nasal cavity. Intervention 2: Intervention group: In the second group, 1 cc of solution for injection Tranexamic Acid, Injection Solution 500mg / 5ml),) with a syringe and poured on the mesh and packed for five minutes immediately after intubation and before making a surgical incision inside the nasal cavity Be. 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 Failure to complete the plan
public Negar shahkarmi
NO, 12. Mirza Hafez Ave
SHiraz Iran (Islamic Republic of) 7195865364 +98 71 3222 0639 negar.shahkarami@yahoo.com Mazandaran University of Medical Sciences scientific Hooshang Akbari
Farah Abad Ave, Mazandaran University of Medical Sciences
Sari Iran (Islamic Republic of) 8137946855 +98 11 3304 4000 hooshangakbari@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Candidate patients for rhinoplasty willingness to participate in the intervention full consciousness age 20-30 years 20 years 30 years Both Sensitivity known to tranexamic acid and phenylephrine Tachycardia and high blood pressure140/90 History of coagulation disorder, warfarin use Sensitivity known to tranexamic acid high blood pressure140/90 History of warfarin use M95.0 Acquired deformity of nose Prevention Prevention Intervention group: In the first group, 1 cc of phenylephrine (Phenylephrine Hcl, Nasal Drop, 0.5%) is drawn with a syringe and poured on the mesh and packed for five minutes immediately after intubation and before making a surgical incision inside the nasal cavity. Intervention group: In the second group, 1 cc of solution for injection Tranexamic Acid, Injection Solution 500mg / 5ml),) with a syringe and poured on the mesh and packed for five minutes immediately after intubation and before making a surgical incision inside the nasal cavity Be Bleeding. Timepoint: Before the intervention, 5, 15 and 30 minutes after the intervention. Method of measurement: Calculation of the amount of blood in the suction and the surgeon's satisfaction with the surgical field. Tachycardia. Timepoint: Before the intervention, 5, 15 and 30 minutes after the intervention. Method of measurement: Using patient vital signs monitoring. Blood pressure. Timepoint: Before the intervention, 5, 15 and 30 minutes after the intervention. Method of measurement: Using patient vital signs monitoring. Mazandaran University of Medical Sciences Approved 2020-08-11 Ethics Committee of Mazandaran University of Medical Sciences Farah abad,Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)