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IRCT20250630066304N1 IRCT 2025-07-13 Mazandaran University of Medical Sciences Evaluation effect of Intravenous Magnesium Sulfate on pain rate afterL4,L5,S1 lumbar spine surgeryin clinical trial Evaluation effect of Intravenous Magnesium Sulfate on pain rate afterL4,L5,S1 lumbar spine surgeryin clinical trial 2025-07-22 anticipated 80 Complete https://irct.ir/trial/84591 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation method will be used. To randomly allocate samples to two intervention groups (receiving magnesium sulfate) and control (receiving normal saline), the blocking method will be used. The blocking process is done with the Random allocation software. Also, the size of each block (4, 6, etc.) is determined by the software, Blinding description: In this design, blinding is done in a double-blind randomization manner. In this way, the patient's assessor and the patient themselves do not know which groups the patient is assigned to. The SNOSE method will be used to conceal (blind) the randomization. This method is one of the common methods for concealing randomization. The interventions are provided to the anesthetist in sealed envelopes. The participants, the principal investigator, and the anesthetist in the neurosurgery room, who are usually responsible for caring for the patients, are unaware of the group allocation, which groups received which drugs, and the type of study. 3 Lumbar disc surgery L4, L5, S1. Intervention 1: Intervention group:Magnesium sulfate is injected once into the patient at a dose of 50 mg/kg of body weight half an hour before the operation from Darupakhsh Pharmaceutical Company, made in Iran. Intervention 2: Control group:Placebo normal saline at a dose of 50 mg/kg body weight half an hour before the operation, injected once, from Darou Pashaek Company, made in Iran, is injected into the patient. 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 No more information available.
public Samira Sobhani
Imam Khomeini Medical Training Center, Amir Mazandarani Boulevard, Sari, Iran
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 Ssobhani1983@gmail.com Mazandaran University of Medical Sciences scientific Samira Sobhani
Imam Khomeini Medical Training Center, Amir Mazandarani Boulevard, Sari, Iran
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 Ssobhani1983@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Confirming the diagnosis with a physical examination, CT scan, and MRI Patient's willingness to participate in the study and obtaining informed consent Candidate for non-emergency discectomy surgery People under 50 years old People with normal kidney function People with no history of heart problems 20 years 50 years Both The patient's unwillingness at any time to continue participating in the study Emergency discectomy surgery Known allergy to one of the study drugs Use of narcotic painkillers up to 12 hours before the intervention Alcohol or drug abuse M51.16 Intervertebral disc disorders with radiculopathy, lumbar region Treatment - Surgery Placebo Intervention group:Magnesium sulfate is injected once into the patient at a dose of 50 mg/kg of body weight half an hour before the operation from Darupakhsh Pharmaceutical Company, made in Iran. Control group:Placebo normal saline at a dose of 50 mg/kg body weight half an hour before the operation, injected once, from Darou Pashaek Company, made in Iran, is injected into the patient. Pain intensity. Timepoint: After surgery and before leaving recovery, 4 and 24 hours after surgery. Method of measurement: Visual Analogue Scale. The amount of nausea and vomiting. Timepoint: After surgery and before leaving recovery, 4 and 24 hours after surgery. Method of measurement: Visual Analogue Scale. Mazandaran University of Medical Sciences Approved 2025-05-12 Research Ethics Committee of Mazandaran University of Sari Medical Sciences, Imam Hospital Imam Khomeini Medical Training Center, Amir Mazandarani Boulevard, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)