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IRCT20230715058778N1 IRCT 2023-07-23 Qazvin University of Medical Sciences Effect of Clonidine on the bleeding of Septorhinoplasty patients Investigating the effect of Clonidine on the amount of bleeding in patients undergoing Septorhinoplasty surgery 2023-08-06 anticipated 54 Complete https://irct.ir/trial/71330 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of random allocation in this study is Balanced Block Randomization. 6 blocks AABB- ABAB_ ABBA- BBAA- BABA_ BAAB are numbered based on 1 to 6 and numbers 1 to 6 are selected from the table of random numbers and placed together. Then they are replaced with numbered blocks, Blinding description: The evaluator gives the pill in an unspecified package to the patient randomly before induction of anesthesia. The surgeon and the clinical caregiver are blinded, and the patient does not know what drug he used and whether this drug was one of the study drugs or part of the hospital's routine. 3 Bleeding during Septorhinoplasty surgery. Intervention 1: Intervention group: Diazepam 0.1 mg per kilogram orally and Clonidine 3 micrograms per kilogram orally 90 minutes before surgery are prescribed by the anesthesiologist in a room with a temperature of 25 degrees Celsius. Intervention 2: Control group: Diazepam 0.1 mg per kilogram is administered orally by an anesthesiologist in a room with a temperature of 25 degrees Celsius. 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 further information
public Mostafa Ghasemi
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
Qazvin Iran (Islamic Republic of) 34199-15315 +98 28 3333 6001 Dr.mostafaghasemi@yahoo.com Qazvin University of Medical Sciences scientific Mostafa Ghasemi
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
Qazvin Iran (Islamic Republic of) 34199-15315 +98 28 3333 6001 Dr.mostafaghasemi@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Candidate for Septorhinoplasty Age range 20-45 Physical class above 2 Willingness to participate in research with informed consent after giving necessary and sufficient explanations about the study 20 years 45 years Both Having any lung disease History of Rhinoplasty surgery History of smoking, alcohol and drugs Chronic mental and physical illness (Schizophrenia, Diabetes, etc.) Vision and hearing problems and other disabilities Long-term use of Corticosteroids, antihistamines, narcotics and painkillers Having diabetes Coagulation disorders Ischemic heart disease History of taking beta blockers or calcium channel blockers patients with systolic blood pressure less than 100 mmHg or heart rate less than 40per minute patients with relative or absolute prohibition of general anesthesia Pregnancy, breast feeding and abortions less than 3 months Y52.5 Other antihypertensive drugs, not elsewhere classified Treatment - Drugs Other Intervention group: Diazepam 0.1 mg per kilogram orally and Clonidine 3 micrograms per kilogram orally 90 minutes before surgery are prescribed by the anesthesiologist in a room with a temperature of 25 degrees Celsius. Control group: Diazepam 0.1 mg per kilogram is administered orally by an anesthesiologist in a room with a temperature of 25 degrees Celsius. The effect of Clonidine on blood pressure during Septorhinoplasty. Timepoint: Systolic and diastolic blood pressure are measured before induction of anesthesia, after intubation of the patient, at the end of surgery and after transfer to recovery. Method of measurement: Blood pressure measurement is done by monitoring device and recorded by evaluator. The effect of clonidine on the amount of bleeding during Septorhinoplasty. Timepoint: After surgery. Method of measurement: The amount of blood in the suction device and the number of completely blood gases. Before the operation, a strong pharyngeal peg is inserted by the surgeon, and at the end of the operation, after the peg is removed, the blood in the nasopharynx is suctioned and added to the amount of bleeding. Effect of Clonidine on heart rate. Timepoint: Before induction of anesthesia, after patient intubation, at the end of surgery and after transfer to recovery. Method of measurement: Monitoring device. Breathing rhythm. Timepoint: Before induction of anesthesia, after patient intubation, at the end of surgery and after transfer to recovery. Method of measurement: Monitoring device. Qazvin University of Medical Sciences Approved 2023-07-14 Ethics Committee of Qazvin University of Medical Sciences Research and Technology deputy, 1st Branch, Maudet Alley, Shahid Beheshti Blvd, Qazvin Qazvin Qazvin Iran (Islamic Republic of)