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IRCT20190911044743N1 IRCT 2020-06-14 Kerman University of Medical Sciences Comparison of the effect of epinephrine injection in rhinoplasty Comparison of the effect of epinephrine injection with two different concentrations on hemodynamic changes and bleeding rate of rhinoplasty in patients under general anesthesia 2020-06-21 anticipated 60 Complete https://irct.ir/trial/47346 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to case or control group according to restricted allocation method and random allocation rule. Allocation concealment will be with sequentially sealed envelopes and technician who is responsible for checking inclusion and exclusion criteria, Blinding description: For all patients, the same forms are filled out by anesthesia technician in charge of the patient.The participant, the filling form technician, the surgeon and the anesthesiologist are not aware of which group the patient is in..Epinephrine with a concentration of 1/200000 or 1/1000000 is prepared by the surgeon's assistant nurse and is given to the surgeon for injection.At the end of anesthesia and after completing the form, the mark of group A or B is written on the forms by the person in charge of collecting the forms. 3 effect of subcutaneus epinephrine on hemodynamic changes and bleeding in rhinoplasty. Intervention 1: Intervention group: solution of subcutaneus epinephrine 1/200000 with lidocaine 2%. Intervention 2: Control group: subcutaneus epinephrine 1/100000 with lidocaine 2%. Yes - There is a plan to make this available What will be shared: All data can be shared When: After completing the statistical design and analysis, all data are reviewed, analyzed and accessible. Start access one month after printing the results To whom: Data are available to academic and scientific researchers Conditions: I don't have any specific conditions yet Where to obtain: Refer to the person in charge of scientific accountability How to obtain: After e-mail and message to the person responsible for scientific response and its review, about a week later, the request will be answered Comments:
public Mohadeseh Ahmadi
Afzalipour Medical School, Shahid Bahonar University, end of 22 Bahman Boulevard, Kerman
kerman Iran (Islamic Republic of) 7616914115 +98 34 3325 7660 mohadeseh7265@gmail.com Kerman University of Medical Sciences scientific Mahdieh Sharifzadeh Kermani
Afzalipour Medical School, Shahid Bahonar University, end of 22 Bahman Boulevard, Kerman
Kerman Iran (Islamic Republic of) 7616914115 +98 34 3325 7660 msharifzade78@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) People aged 16-45 years ASA I,II 16 years 45 years Both Coagulation disorder Heart disease hypertension Cerebrovascular disease Renal disease drug Allergies Treatment - Drugs Treatment - Drugs Intervention group: solution of subcutaneus epinephrine 1/200000 with lidocaine 2% Control group: subcutaneus epinephrine 1/100000 with lidocaine 2% Systolic and diastolic and mean arterial pressure. Timepoint: Before inductin by anesthesia, after intubation and then at intervals before anesthesia, after intubation, immediately before epinephrine injection, and then every minute to the third minutes after injection, and then every 5 minutes until the end of the procedure. Method of measurement: Non-invasive automatic measurement by a monitoring device. Heart rate. Timepoint: Before inductin by anesthesia, after intubation and then at intervals before anesthesia, after intubation, immediately before epinephrine injection, and then every minute to the third minutes, and then every 5 minutes until the end of the procedure. Method of measurement: EKG monitoring. Rate of bleeding. Timepoint: End of surgury. Method of measurement: Measurment of blood in bottle of suction and number of bloody gases. Volume of infused propofol. Timepoint: End of surgery. Method of measurement: Volume of infusion in milliliter. Volume of infused remifentanil. Timepoint: End of surgery. Method of measurement: Volume of infusion in milliliter. Kerman University of Medical Sciences Approved 2020-02-03 Research Ethics Committee of Kerman University of Medical Sciences Beginning of Ibn Sina street-first Jahad boulevard-Somayeh intersection (Tahmasb Abad)-Kerman-Iran Kerman Kerman Iran (Islamic Republic of)