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IRCT20170408033291N2 IRCT 2019-03-31 Qazvin University of Medical Sciences The effect of Atracurium and Cisatracurium on post-operative shivering The effect of Atracurium and Cisatracurium on post-operative shivering in orthopedic surgery of the lower limbs 2019-04-20 anticipated 60 Complete https://irct.ir/trial/38319 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly (using computer software) divided into two groups of 30 cases (A and B). Using a computer, random numbers are generated between 0 and 1. If the generated random number is less than 0.5, the patient is assigned to group A, and if it is greater than 0.5, the patient is assigned to group B, Blinding description: In this study patients and investigator are not inform of the treatment groups allocation. Treatment is written on a piece of paper and puts into one envelope and is encrypted confidentially by supervisor. 3 Post operative shivering. Intervention 1: Intervention group: Group A: Atracurium is injected intravenously with an initial dose of 0.5- 0.6 mg / kg and a concentration of 25 to 50 mg /ml. A preservative dose for muscle relaxation is injected intravenously with dose of 0.1- 0.2 mg/kg upon the onset of muscle relaxation. Company: Caspian. Intervention 2: Intervention group: Group B: Cisatracurium is injected intravenously with an initial dose of 0.15- 0.2 mg /kg body weight and a concentration of 2 to 10 mg /ml. A preservative dose for muscle relaxation is injected intravenously with dose of 0.03 mg /kg, 40-60 minutes after the initial dose and upon the onset of muscle relaxation. Company: Caspian. 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 Ahmad Karami
Shahid Rajaeei Hospital, Padegan Street, Qazvin
Qazvin Iran (Islamic Republic of) 3419759811 +98 28335800 akkarami1344@gmail.com Qazvin University of Medical Sciences scientific Ali Alizadeh
Shahid Bahonar blvd., Qazvin
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3333 5800 a.alizadeh@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients who completed informed consent form Being at the age of 20 to 60 years old Patients in class I and II based on the American Society of Anesthesiologists (ASA) classification 20 years 60 years Both Underlying illnesses Allergy to anesthetic drugs• Severe allergic to eggs and soy (in relation to propofol)• Abnormal responses to non-depolarized musculoskeletal muscle relaxants such as myasthenia gravis and musculoskeletal disorders, addiction (Narcotics, stimulants and energetic and alcohol) Lake of patient satisfaction to participate in the study Central and peripheral nervous diseases - Multiple trauma Y55.2 Post operative shivering Treatment - Drugs Treatment - Drugs Intervention group: Group A: Atracurium is injected intravenously with an initial dose of 0.5- 0.6 mg / kg and a concentration of 25 to 50 mg /ml. A preservative dose for muscle relaxation is injected intravenously with dose of 0.1- 0.2 mg/kg upon the onset of muscle relaxation. Company: Caspian. Intervention group: Group B: Cisatracurium is injected intravenously with an initial dose of 0.15- 0.2 mg /kg body weight and a concentration of 2 to 10 mg /ml. A preservative dose for muscle relaxation is injected intravenously with dose of 0.03 mg /kg, 40-60 minutes after the initial dose and upon the onset of muscle relaxation. Company: Caspian. Postoperative Shivering. Timepoint: After surgery. Method of measurement: Shivering is evaluated based on the 0-3 scale. Zero (without shivering), grade 1 (mild), grade 2 (moderate), and grade 3 (Severe). Qazvin University of Medical Sciences Approved 2019-03-11 Ethics Committee of Qazvin University of Medical Sciences Shahid Bahonar Blvd., Qazvin Qazvin Qazvin Iran (Islamic Republic of)