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IRCT20221202056688N1 IRCT 2022-12-17 Kerman University of Medical Sciences Investigating the effect of the combination of a cardiovascular drug and an anesthetic drug on the amount of bleeding during nose surgery The effect of medication including dexmedetomidine + remifentanil VS remifentanil on bleeding during rhinoplasty surgery 2023-02-04 anticipated 70 Complete https://irct.ir/trial/67188 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Randomization is simple and using a table of random numbers. First, the direction of reading the numbers in the table is determined, then we move by placing our hands on a number and according to the predetermined reading direction, even numbers represent the intervention group and odd numbers represent the group. The control is used to hide sealed envelopes, Blinding description: Blinding is in such a way that only the anesthesiologist is aware of the type of drug used, and the patients, the outcome assessor, and the surgeon are unaware of the grouping and type of drugs. 3 The amount of bleeding during rhinoplasty surgery. Intervention 1: Intervention group: receiving dexmedetomidine with a loading dose of 1.0-0.5 μg/kg and a maintenance dose (0.5-0.3 μg/kg/h) and remifentanil with a maintenance dose (0.5-0.25 mcg/kg/min IV) in the form of infusion. will receive. Intervention 2: Control group: receiving remifentanil with a maintenance dose (0.25-0.5 mcg/kg/min IV). Yes - There is a plan to make this available What will be shared: It is possible to share all data without mentioning people's names and privacy. When: 2 months after data analysis To whom: Health researchers Conditions: In order to use the results and during the written request Where to obtain: Elnaz Rahmani- Email: elnaz_rahmani26@yahoo.com How to obtain: The purpose of accessing data - requesting e-mail Comments:
public Elnaz Rahmani
Havanirooz
Kerman Iran (Islamic Republic of) 7618187568 +98 34 3285 0395 elnaz_rahmani26@yahoo.com Kerman University of Medical Sciences scientific Jafar Salehi
Gharani
kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 dr.jsalehi@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Rhinoplasty surgery candidate No history of nose surgery Not suffering from chronic and severe diseases (diabetes, high blood pressure, cancer, etc.) patients with physical class higher than 2 18 years 50 years Both Patients with systolic blood pressure less than 100 mm Hg Heart rate less than 60 per minute Patients with relative or absolute prohibition of general anesthesia Patients with chronic drug or alcohol use Specific use of any interfering drug during anesthesia Z42.0 Follow-up care involving plastic surgery of head and neck Treatment - Drugs Treatment - Drugs Intervention group: receiving dexmedetomidine with a loading dose of 1.0-0.5 μg/kg and a maintenance dose (0.5-0.3 μg/kg/h) and remifentanil with a maintenance dose (0.5-0.25 mcg/kg/min IV) in the form of infusion. will receive Control group: receiving remifentanil with a maintenance dose (0.25-0.5 mcg/kg/min IV) Bleeding volume. Timepoint: After the operation is completed. Method of measurement: Calculating the amount of blood in the suction, sterile gases and the surgeon's satisfaction with the surgical field. Blood pressure. Timepoint: Before the operation, 15-30-45 minutes after the start of the intervention and the end of the operation. Method of measurement: By monitoring the patient's vital signs. Heart rate. Timepoint: Before the operation, 15-30-45 minutes after the start of the intervention and the end of the operation. Method of measurement: By monitoring the patient's vital signs. Kerman University of Medical Sciences Approved 2022-08-02 Ethics committee of kerman University of Medical Sciences Kerman University of Medical Sciences Campus, The beginning of Haft Bagh Alavi Road, Kerman,Iran Kerman Kerman Iran (Islamic Republic of)