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IRCT20211226053537N1 IRCT 2022-01-23 Karaj University of Medical Sciences Comparison of the effect of intravenous meperidine injection with dexamethasone and midazolam on shivering after orthopedic surgery Comparison of the effect of intravenous injection of meperidin with dexamethasone and midazolam onpostoperative shivering in patients recovering from general anaesthesia in post orthopedic surgery 2022-02-20 anticipated 120 Complete https://irct.ir/trial/60918 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Our sample size is 120people, with 40 people in each group. Block randomization method was designed by epidemiologist using STATA version 13 software. The number of blocks considered is 6, Blinding description: The random allocation list will solely available to the epidemiologist. 120 cards containing sequences of treatments will be written and be placed inside sealed envelopes. A10-digit random code, as the patient’s identification number, will be provided for each packet. When the physician announces the eligibility of a patient, the nurse will provide the physician with the envelope. None of the patients should be aware of the type and process of treatment. Also, the person evaluating the outcomes is a third person who is unaware of the random allocation process and type of treatment. Data analysis will be carried out by a statistician who is aware of all the processes performed. 3 Shivering after surgery. Intervention 1: Intervention group 1: participants will received meperidine (Exire, Iran)at a dose of 0.4 mg per kg. Intervention 2: Intervention group2: participants will received dexamethasone (Alborz daro,Iran) at a dose of 0.15 mg per kg. Intervention 3: Intervention group3: participants will received midazolam(shimi daro,Iran) at a dose of 0.05 mg per kg. 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 It is not yet known if there will be a plan to make this available
public Maryam Cheraghali
Karaj, Madani Square, Madani Hospital
Karaj Iran (Islamic Republic of) ۳۱۴۳۷۴۴۶۹۳ +98 21 2275 2546 cheraghalimaryam@yahoo.com Karaj University of Medical Sciences scientific Maryam Cheraghali
Karaj, Madani Square, Madani Hospital
Karaj Iran (Islamic Republic of) ۳۱۴۳۷۴۴۶۹۳ +98 21 2275 2546 cheraghalimaryam@yahoo.com Karaj University of Medical Sciences Iran (Islamic Republic of) Patients undergoing elective orthopedic surgery At least 8 hours of fasting Ages between 18 and 65 years ASA class 1,2 18 years 65 years Both hypothermia hyperthermia Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: participants will received meperidine (Exire, Iran)at a dose of 0.4 mg per kg Intervention group2: participants will received dexamethasone (Alborz daro,Iran) at a dose of 0.15 mg per kg Intervention group3: participants will received midazolam(shimi daro,Iran) at a dose of 0.05 mg per kg Shivering after general anesthesia. Timepoint: In the meperidine group and the midazolam group; 2 minutes and in the dexamethasone group 5 minutes after injection. Method of measurement: Observation. Karaj University of Medical Sciences Approved 2022-01-04 Ethics committee of Alborz University of Medical Sciences Ethics committee unit; Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street Karaj Alborz Iran (Islamic Republic of)