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IRCT20211107052990N1 IRCT 2021-12-08 Karaj University of Medical Sciences The effect of single dose prophylactic intravenous Aminophylline on prevention of postoperative shivering following surgery The effect of single dose prophylactic intravenous Aminophylline on prevention of postoperative shivering following lower limb orthopedic surgeries under spinal anaesthesia. 2021-12-22 anticipated 60 Complete https://irct.ir/trial/60232 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Our sample size is 60 people, with 30 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. 60 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 spinal anesthesia. Intervention 1: Intervention group: Patients receive intavenously 1.5 mg / kg Aminophylline Ampul , made by pharmaceutical company, in 100 cc of normal saline . Intervention 2: Control group: Patients receive intravenously normal saline . 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 Mahtab Dolatabadi
No. 92, Takhti Ave., Golestan Blvd., Azimie
Karaj Iran (Islamic Republic of) ۳۱۵۵۷۳۱۸۹۶ +98 26 3220 4276 mahtab.dolatabadi@gmail.com Karaj University of Medical Sciences scientific Mahtab Dolatabadi
No. 92, Takhti Ave., Golestan Blvd., Azimie
Karaj Iran (Islamic Republic of) ۳۱۵۵۷۳۱۸۹۶ +98 26 3220 4276 mahtab.dolatabadi@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Patients with PS ASA grade 1 BMI 19 to 26 Having a full fast Candidate for lower limb orthopedic surgery under spinal anesthesia Age between 20-40 years 20 years 40 years Both Contraindications to spinal anesthesia Surgery duration more than 90 minutes Bleeding more than 0.5 liters Sensitivity to aminophylline Taking drugs that interfere with aminophylline Tachycardia greater than 110 beats per minute or history of arrhythmia prior to injection History of untreated hyperthyroidism or hypothyroidism Anemia (Hb <12) Extensive burns History of hyperthermia Malignant Receiving blood or cold liquids (<37) sur Prevention Placebo Intervention group: Patients receive intavenously 1.5 mg / kg Aminophylline Ampul , made by pharmaceutical company, in 100 cc of normal saline . Control group: Patients receive intravenously normal saline . Shivering after spinal anesthesia. Timepoint: After discharge from recovery. Method of measurement: Based on the patient's statement and the doctor's opinion. Body temperature. Timepoint: After discharge from recovery. Method of measurement: Temperature. Vital Sign. Timepoint: After discharge from recovery. Method of measurement: Heart rate monitor, sphygmomanometer. Karaj University of Medical Sciences Approved 2021-11-02 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)