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IRCT20130311012782N53 IRCT 2021-03-15 Esfahan University of Medical Sciences Comparison of injection of two different amounts of dexmedetomidine on blood pressure, heart rate and postoperative pain Comparative study of the effect of two-dose infusion of 0.3 and 0.6 μg / kg dexmedetomidine during surgery on changes in hemodynamic parameters and pain in patients undergoing spinal surgery under general anesthesia 2021-04-03 anticipated 81 Complete https://irct.ir/trial/54777 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are distributed in three groups by simple random allocation method. To do this, the letter A is written on 27 cards, the letter B is written on 27 cards and the letter C is written on 27 cards, and all the cards are put in a box and shuffled well. At the time of each patient's visit, he / she is asked to take a card out of the box. According to the letter written on the card, the patient is assigned to the group of dexmedetomidine 0.3, dexmedetomidine 0.6 or control group, Blinding description: The study is done in three blinds. Patient researchers and analysts are unaware of patients being assigned to groups. The drugs are prepared by an operating room staff who is not in the study, in similar and coded syringes, and are given to the researcher for injection. After analyzing the data, the codes are opened and the results are compiled accordingly. 3 Disk herniation. Intervention 1: Intervention group1: Patients receiving intravenous infusion of 0.3 μg / kg dexmedetomidine at the time of induction of anesthesia. Intervention 2: Intervention group2: Patients receiving intravenous infusion of 0.6 μg / kg dexmedetomidine at the time of induction of anesthesia. Intervention 3: Control group: Patients undergoing normal saline intravenous infusion with similar volume of intervention drugs at the time of induction of anesthesia. No - There is not a plan to make this available Justification or reason for not sharing IPD is The plan belongs to a government agency and cannot be shared.
public Mahshad Rahimian
Department of Anesthesiology, Alzahra hospital, Sofeh street
Isfahan Iran (Islamic Republic of) 8434193474 +98 31 3669 2174 k.mahshad-net@yahoo.com Esfahan University of Medical Sciences scientific Mehrdad Masoudifar
Department of Anesthesiology, Alzahra hospital, Sofeh street
Isfahan Iran (Islamic Republic of) 8434193474 +98 31 3669 2174 m_masoudifar@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Candidate for spinal laminectomy under general anesthesia ASA(American Society of Anesthesiologists) 1 & 2 Patient consent to participate in the study 18 years 65 years Both History of kidney and liver disease History of allergy to any anesthetic drug Heart failure or a history of miocardial infarction Drug and alcohol addiction or mental illness Pregnancy M51:26 Disk herniation Treatment - Drugs Treatment - Drugs Placebo Intervention group1: Patients receiving intravenous infusion of 0.3 μg / kg dexmedetomidine at the time of induction of anesthesia Intervention group2: Patients receiving intravenous infusion of 0.6 μg / kg dexmedetomidine at the time of induction of anesthesia Control group: Patients undergoing normal saline intravenous infusion with similar volume of intervention drugs at the time of induction of anesthesia. Blood pressure. Timepoint: Every half hour during surgery and recovery. Method of measurement: Pulse Oximeter. Hear rate. Timepoint: Every half hour during surgery and recovery. Method of measurement: Pulse Oximeter. Percentage of blood oxygen saturation. Timepoint: Every half hour during surgery and recovery. Method of measurement: Pulse Oximeter. Post operative pain. Timepoint: Every 30 minutes from the enterance to recovery and 2, 8, 24 and 48 hours after surgery. Method of measurement: Using a visual analog scale(VAS) that divides patients' pain intensity from zero to 10. Esfahan University of Medical Sciences Approved 2020-05-18 Ethics committee of Isfahan University of Medical Sciences Research deputy, Isfahan University of Medical Sciences, Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)