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IRCT20160403027191N3 IRCT 2020-12-07 Mazandaran University of Medical Sciences Effect of Meperedin and Ketamin in prevention of shivering Comparison effects of intravenous ketamine with intrathecal meperidine in prevention of shivering in elective orthopedic surgery of lower extremity with spinal anesthesia 2017-03-21 anticipated 150 Complete https://irct.ir/trial/22333 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: A total of 150 patients were randomly divided into three groups: intervention Ketamine (K), intervention Meperidine (M) and control group (C) using a list of computer random numbers. This was done by an anesthesia technician who was a fellow project, Blinding description: The study was double-blind and the statistician, project physicians and patients were unaware of the patients' placement in the treatment groups and the data collection form was filled in by the project partner nurse who was unaware of the study groups. The lead researcher who injects the drug, as well as the medical staff responsible for caring for patients, are blinded. 3 Shivering. Intervention 1: Group K: Bupivacaine 0.5% 15 mg, which was increased to 4 ml with normal saline, was injected intrathecally, and immediately after spinal anesthesia, ketamine 0.5 mg / kg, which was reduced to 5 ml with normal saline. It was injected intravenously. Intervention 2: Intervention group: Group M: bupivacaine 0.5% 15 mg and meperidine 0.2 mg / kg which was increased to 4 ml with normal saline and injected intrathecally and 5 ml normal saline was injected intravenously. Intervention 3: Control group:Group C: Normal saline 5 ml intravenously and bupivacaine 0.5% 15 mg with normal saline volume 4 cc was injected intrathecally. No - There is not a plan to make this available Justification or reason for not sharing IPD is The study has already been done and the data is not available
public Abdolmajid Gholi Nataj Jelodar
Amir Mazandarani street
Sari Iran (Islamic Republic of) 4815733971 +98 11 3325 5348 gholinataj54@mazums.ac.ir Mazandaran University of Medical Sciences scientific Abdolmajid Gholinataj Jelodar
Amir Mazandarani street
Sari Iran (Islamic Republic of) 4815733971 +98 11 3325 5348 gholinataj54@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) The patient's desire to participate in the study and gain informed consent Elective lower extremity orthopedic surgery under spinal anesthesia Age>18and Age<65 ASA 1 and 2 18 years 65 years Both Treatment - Drugs Treatment - Drugs Treatment - Drugs Group K: Bupivacaine 0.5% 15 mg, which was increased to 4 ml with normal saline, was injected intrathecally, and immediately after spinal anesthesia, ketamine 0.5 mg / kg, which was reduced to 5 ml with normal saline. It was injected intravenously. Intervention group: Group M: bupivacaine 0.5% 15 mg and meperidine 0.2 mg / kg which was increased to 4 ml with normal saline and injected intrathecally and 5 ml normal saline was injected intravenously. Control group:Group C: Normal saline 5 ml intravenously and bupivacaine 0.5% 15 mg with normal saline volume 4 cc was injected intrathecally. The amount of shivering. Timepoint: From three minutes after the onset of anesthesia to two hours later at twenty-minute intervals. Method of measurement: Shivering chart. Body temperature. Timepoint: From three minutes after spinal anesthesia to two hours later at intervals of every twenty minutes. Method of measurement: Termometr. Mean Arterial Pressure. Timepoint: From three minutes after spinal anesthesia to two hours later at intervals of every twenty minutes. Method of measurement: Saadat automatic pressure gauge. Mazandaran University of Medical Sciences Approved 2016-04-29 Ethics committee of Mazandaran University of Medical Sciences Anesthesiology department ,Emam Khomeini Hospiral, Amir Mazandarani street Sari Mazandaran Iran (Islamic Republic of)