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IRCT20230810059108N1 IRCT 2023-08-21 Shahid Beheshti University of Medical Sciences Effect of magnesium sulfate on anesthesia consumption and pain after spinal surgery Comparison of different doses of Intravenous magnesium sulfate on intraoperative anesthetic drugs usage and post operative pain in Posterior Spinal Fusion surgery 2023-08-13 anticipated 80 Complete https://irct.ir/trial/72017 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this clinical trial study, after obtaining the approval of ethics committee, candidates for posterior spinal fusion surgery who meet the inclusion criteria will be selected and patients will be randomly divided into two groups M (1, 2 , 3) and S (control) that receive equal volume of placebo (normal saline). Each patient will be given a sealed envelope containing the information of the study or control group and will be opened by the designated nurse in the operating room. Patients are blind to the study group or placebo. But the anesthesiologist in the operating room will be aware of the type of drug received and the drugs studied by an anesthesiologist will be prepared and prescribed for everyone, patients and other members of the research group will not be aware of the intervention group .Simple random sampling is using random table of numbers, Blinding description: In this clinical trial study, after obtaining the approval of ethics committee, candidates for posterior spinal fusion surgery who meet the inclusion criteria will be selected and patients will be randomly divided into two groups M (1, 2 , 3) and S (control) that receive equal volume of placebo (normal saline). Each patient will be given a sealed envelope containing the information of the study or control group and will be opened by the designated nurse in the operating room. Patients are blind to the study group or placebo. But the anesthesiologist in the operating room will be aware of the type of drug received and the drugs studied by an anesthesiologist will be prepared and prescribed for everyone, patients and other members of the research group will not be aware of the intervention group. 3 Magnesium Sulfate. Intervention 1: First Intervention group (M1): At first, 50 mg/kg magnesium sulfate is given intravenous bolus for 15 minutes and then infusion of intravenous magnesium sulfate is 10 mg/kg/h. Intervention 2: Second intervention group (M2): At first, 50 mg/kg magnesium sulfate is given intravenous bolus within 15 minutes and then infusion of intravenous magnesium sulfate is 15 mg/kg/h. Intervention 3: Third intervention group (M3): First, 50 mg/kg of magnesium sulfate is given intravenous bolus during 15 minutes and then the infusion of 20 mg/kg/hr of magnesium sulfate. Intervention 4: Control group(S): The control group will be given a dose of bolus normal saline equal to the volume of the intervention group during 15 minutes of continuous to the end of the operation. Yes - There is a plan to make this available What will be shared: The whole data is potentially shareable after making people unidentifiable. When: Start of access period 1 month after publication of results To whom: Researchers working in academic and scientific institutions Conditions: For the purpose of academic research Where to obtain: neshat.a15@gmail.com How to obtain: For the purpose of academic research Comments:
public Neshat Abdi
Loghman Hakim Hospital.Makhsoos Ave.South Kargar Ave
Tehran Iran (Islamic Republic of) 1333635445 +98 912 078 6983 neshat.a15@gmail.com Shahid Beheshti University of Medical Sciences scientific Neshat Abdi
Loghman Hakim Hospital,Makhsoos Ave.South Kargar Ave
Tehran Iran (Islamic Republic of) 1333635445 +98 912 078 6983 neshat.a15@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 18-65 years no history of drug sensitivity no history of thromboembolism no liver, heart or kidney failure, and coagulation disorders no anticoagulant drugs usage no severe obesity no neuromascular disease no calcium channel blockers usage physical class of American Society of Anesthesiology I,II (ASA) and patient satisfaction to participate in the study 18 years 65 years Both Surgery time greater than 5 hours Changing the Surgical Procedure Bleeding more than 2 liters and requires massive transfusion Sustained blood pressure drop of more than 25% basal BP Z98.8 Other specified postsurgical states Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo First Intervention group (M1): At first, 50 mg/kg magnesium sulfate is given intravenous bolus for 15 minutes and then infusion of intravenous magnesium sulfate is 10 mg/kg/h. Second intervention group (M2): At first, 50 mg/kg magnesium sulfate is given intravenous bolus within 15 minutes and then infusion of intravenous magnesium sulfate is 15 mg/kg/h. Third intervention group (M3): First, 50 mg/kg of magnesium sulfate is given intravenous bolus during 15 minutes and then the infusion of 20 mg/kg/hr of magnesium sulfate. Control group(S): The control group will be given a dose of bolus normal saline equal to the volume of the intervention group during 15 minutes of continuous to the end of the operation. Postoperative pain. Timepoint: 6.12.24 hours after surgery. Method of measurement: Numerical Rating Scale. Dosage of Anesthetic Drugs. Timepoint: During surgery. Method of measurement: Bispectral Index. Shahid Beheshti University of Medical Sciences Approved 2023-07-25 Ethics committe of Shahid Beheshti University of Medical Science Loghman Hakim Hospital,Makhsoos Ave.South Kargar Ave Tehran Tehran Iran (Islamic Republic of)