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IRCT20230523058274N1 IRCT 2023-07-07 Yazd University of Medical Sciences Comparison of the effects of clonidine and tranexamic acid on the amount of bleeding during tympanoplasty Comparison between effect of oral clonidine and tranexamic acid on bleeding during tympanoplasty surgery 2023-07-23 anticipated 62 Complete https://irct.ir/trial/70307 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this triple-blind clinical trial study, 62 patients who are candidates for tympanoplasty, referring to Namazi Hospital, will be randomly included in the study. Block randomization will be used to randomly assign people in the study groups (intervention group and comparison group). In this method, blocks of 6 (including three people in the intervention group and three people in the comparison group) will be used with a ratio of 1:1. Random Allocation software will be used to generate random sequences. For concealment, the random allocation concealment method will be used in such a way that the random sequences created in this method are recorded on cards and these cards will be placed in sealed envelopes in order. In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, based on the order of arrival of the eligible participants, the envelopes will be opened and the assigned group of that participant will be known, Blinding description: In this three-blind clinical trial study, random allocation concealment method will be used for concealment, in such a way that the random sequences created in this method are recorded on cards and these cards are placed in sealed envelopes. They will be placed in order. In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, based on the order of arrival of the eligible participants, the envelopes will be opened and the assigned group of that participant will be known. The researcher, who is also the outcome assessor, did not know about the grouping, the patients did not know about the grouping and the medicine received, and the data analyzer did not know about the assigned groups. 3 Condition 1: Tympanoplasty. Condition 2: Hemorrhage. Intervention 1: Intervention group: 90 minutes before the operation, 200 micrograms of clonidine was administered to one group. Intervention 2: Intervention group: 90 minutes before the operation for one group, 200 micrograms of transgrammic acid was given. Yes - There is a plan to make this available What will be shared: Only a part of the data, such as the information related to the main outcome or the like, can be shared. When: One year after the time of publication To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: The data will be available only to researchers working in academic and scientific institutions Where to obtain: The data will only be available to researchers working in academic and scientific institutions through the following email address. fatemehizadabadi@gmail.com How to obtain: Only the data related to the main results of the study can be presented to the mentioned people after mentioning the valid reason. Comments:
public Fatemeh Izadabadi
Unit 5, 3rd Floor, Mehrdad Building, No. 6, Alley 10, Sanatgar St., Amir Kabir Blvd., Shiraz
SHiraz Iran (Islamic Republic of) 7176884349 +98 917 687 7023 fatemehizadabadi@gmail.com Shiraz University of Medical Sciences scientific Fatemeh Izadabadi
Unit 5, 3rd Floor, Mehrdad Building, No. 6, Alley 10, Sanatgar St., Amir Kabir Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7176884349 +98 71 3837 4599 fatemehizadabadi@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 60 are candidates for tympanoplasty 18 years 60 years Both Treated with tricyclic antidepressants or monoamine oxidase inhibitors Patients with heart, liver, kidney diseases and severe mental disorders Patients with systolic blood pressure above 160 mmHg and diastolic blood pressure above 90 mmHg. Heart rate less than 50 per minute H60.10 R58 Cellulitis of external ear, unspecified ear Hemorrhage, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: 90 minutes before the operation, 200 micrograms of clonidine was administered to one group. Intervention group: 90 minutes before the operation for one group, 200 micrograms of transgrammic acid was given. Bleeding. Timepoint: During tympanoplasty surgery. Method of measurement: A 4-point scoring system was evaluated, 0 = no bleeding, 1 = brief (suction rarely), 2 = heavy bleeding (frequent suction) and 3 = very heavy bleeding (conditions of surgical problem and continuous suction). Hemodynamic variables. Timepoint: It was recorded every 10 minutes before and after pre-drug injection, after induction of anesthesia, after intubation, before surgery and then during surgery. Method of measurement: توسط پرسشنامه. Research Vice President of Shiraz University of Medical Sciences Approved 2022-04-03 Ethics committee of Shiraz University of Medical Sciences Unit 5, 3rd Floor, Mehrdad Building, No. 6, Alley 10, Sanatgar St., Amir Kabir Blvd., Shiraz Shiraz Fars Iran (Islamic Republic of)