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IRCT20171228038117N4 IRCT 2020-06-01 Semnan University of Medical Sciences Effect of Magnesium Sulfate and ondansetron in Prevention of Shivering in Patients during Spinal Anesthesia Comparison of Effect of Magnesium Sulfate and ondansetron in Prevention of Shivering in Patients during Spinal Anesthesia 2020-05-21 anticipated 80 Complete https://irct.ir/trial/47440 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize the study, 80 cards in two different colors, 40 red cards and 40 Blue cards was poured into a bag for the Ondansteron and Magnesium Sulfate groups, respectively, and was randomly drawn by an anesthesia technician, and a card was drawn and discarded for each patien, Blinding description: Patients' Shivering were measured every 15 to 90 minutes by a person other than the researcher who did not know the study group and were recorded in a special form. Due to the nature of the intervention and the design of the study, only the researcher is aware of the injection. Patients will be unaware that they belong to the intervention or control group. Also, the statistician is not aware of the patients' identities and only collects information through a numerical list that does not have the names of the patients. As a result, the study will be double-blind, and prevention will be achieved. due to differences in the treatment of patients. Also, syringes containing the drug and normal saline are identical in appearance. 3 Comparison of Effect of Magnesium Sulfate and ondansetron in Prevention of Shivering in Patients during Spinal Anesthesia. Intervention 1: Intervention group 1:30 Milligrams per kilogram diluted magnesium sulfate 50% from Shahid Ghazi Pharmaceutical Co with 500 cc of normal saline is infused over 30 minutes by the pump syringe. The maximum dose of magnesium was 4 gram. Intervention 2: Intervention group 2: ondansetron 4 miligram per 2 CC Caspian Tamin Pharmaceutical Companyis infused at 0.1 Milligrams per kilogram with 500 cc of normal saline for 30 minutes. 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 Need to review
public babak hoseinzadeh
9771No. 9771., Imam Hossein Square
Semnan Iran (Islamic Republic of) : 35197-34731 +98 23 3346 0055 babak.hoseinzadeh@semums.ac.ir Semnan University of Medical Sciences scientific babak hoseinzadeh
9771No. 9771., Imam Hossein Square
Semnan Iran (Islamic Republic of) 34731-35197 +98 23 3346 0055 babak.hoseinzadeh@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) pregnant women with American Society of Anesthesia class I who have a cesarean section with spinal anesthesia no limit no limit Female pregnant women with American Society of Anesthesia class II , III , IV Fever ( Central body temperature over 38 Celsius ) or hypothermia ( Central body temperatureless than 36.5 Celsius ) contraindications of spinal anesthesia allergy to the drugs studied recieving blood during surgery use of petidine and magnesium before surgery Treatment - Drugs Treatment - Drugs Intervention group 1:30 Milligrams per kilogram diluted magnesium sulfate 50% from Shahid Ghazi Pharmaceutical Co with 500 cc of normal saline is infused over 30 minutes by the pump syringe. The maximum dose of magnesium was 4 gram Intervention group 2: ondansetron 4 miligram per 2 CC Caspian Tamin Pharmaceutical Companyis infused at 0.1 Milligrams per kilogram with 500 cc of normal saline for 30 minutes. Shiver. Timepoint: 15 minute. Method of measurement: Crossley Mahajan criteria. Temperature. Timepoint: 15 Minute. Method of measurement: Blood pressure device. Age. Timepoint: same time. Method of measurement: Age by year. Heart Rate. Timepoint: 15 minute. Method of measurement: monitoring. O2 Saturation. Timepoint: 15 minute. Method of measurement: pulse oxymetry. Nausea Vomiting. Timepoint: 15 minute. Method of measurement: observation. Semnan University of Medical Sciences Approved 2020-03-14 Ethics committee of Semnan University of Medical Sciences Headquarter of Semnan University of Medical Sciences and Health Services., Basij Blvd after Amirkabir Bridge Semnan Semnan Iran (Islamic Republic of)