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IRCT20141209020258N153 IRCT 2021-03-09 Arak University of Medical Sciences Comparison of intrathecal injections of Meperidine, Teramadol, Magnesium sulfate and Dexmedetomidine in prevention of shivering and postoperative complications of femoral fracture repair under spinal anesthesia Comparison of intrathecal injections of Meperidine, Teramadol, Magnesium sulfate and Dexmedetomidine in prevention of shivering and postoperative complications of femoral fracture repair under spinal anesthesia 2021-03-15 anticipated 132 Complete https://irct.ir/trial/54731 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with random allocation with envelopes in 4 groups A and B and C and D. In this method, we selected a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size, Blinding description: Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping. 2-3 Femoral fracture repair under spinal anesthesia. Intervention 1: Intervention group: They receive 5 micrograms of dexmedetomidine along with 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 ml). (Dexmedetomidine Elixir Pharmaceutical Company - Iran). Intervention 2: Intervention group: They receive 25 mg of magnesium sulfate along with 5.12 mg of hyperbaric bupivacaine 0.5% (2.5 ml). (Magnesium sulfate 10% Pasteur Institute Pharmaceutical Company - Iran). Intervention 3: Intervention group: They receive 0.2 mg / kg of meperidine along with 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 ml). Mepridine Gerot Pharmaceutical Company Vienna - Austria (Order of Darupakhsh Company). Intervention 4: Intervention group: They receive 10 mg of tramadol (0.2 ml of tramadol hydrochloride 50 mg / ml) along with 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 ml). (Travadol Caspian Tamin Rasht Pharmaceutical Company - Iran). 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 more information
public Dr Esmaeel Moshiri
Valiasr hospital, Valiasr square, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific Dr Hesamedin Modir
Valiasr hospital, Valiasr square, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Age: 18 to 75 years old Both sexes ASA Class 1 and 2 Femoral fracture repair under spinal anesthesia No history of drug addiction No history of seasonal allergies as well as allergies to any of the drugs used in this study Absence of neuromuscular diseases Absence of Raynaud's disease Absence of cardiomyopathy Absence of coagulation disease 18 years 75 years Both Failure in anesthesia and other methods Dissatisfaction with continuing to participate in the project T88.5 Other complications of anaesthesia Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: They receive 5 micrograms of dexmedetomidine along with 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 ml). (Dexmedetomidine Elixir Pharmaceutical Company - Iran) Intervention group: They receive 25 mg of magnesium sulfate along with 5.12 mg of hyperbaric bupivacaine 0.5% (2.5 ml). (Magnesium sulfate 10% Pasteur Institute Pharmaceutical Company - Iran) Intervention group: They receive 0.2 mg / kg of meperidine along with 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 ml). Mepridine Gerot Pharmaceutical Company Vienna - Austria (Order of Darupakhsh Company) Intervention group: They receive 10 mg of tramadol (0.2 ml of tramadol hydrochloride 50 mg / ml) along with 12.5 mg of hyperbaric bupivacaine 0.5% (2.5 ml). (Travadol Caspian Tamin Rasht Pharmaceutical Company - Iran) Shivering intensity. Timepoint: In recovery and every 15 minutes to 2 hours and then every 2 hours to 12 hours. Method of measurement: Fourth criterion (0-3): 0 means no shivering, 1 means mild fasciculation of the face and neck, 2 means visible tremor in more than one muscle, and 3 means intense muscle activity throughout the body. Sedation. Timepoint: During the operation and up to 12 hours after the operation. Method of measurement: Ramsay Sedation Scale. Arak University of Medical Sciences Approved 2021-01-13 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre, Sardasht,Arak Arak Markazi Iran (Islamic Republic of)