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IRCT20231114060049N1 IRCT 2023-11-14 Ahvaz University of Medical Sciences Comparing the effect of magnesium sulfate with dexmedetomidine in epidural block with bupivacaine half percent Comparison of the effect of magnesium sulfate and bupivacaine on dexmedetomidine and bupivacaine in the epidural block of patients undergoing orthopedic surgery 2023-03-14 anticipated 50 Complete https://irct.ir/trial/73729 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the patients are randomized and based on the quadruple permutation block method, Blinding description: The patient, the doctor and the person who fills in the questionnaire do not know how people are placed in the groups. 3 orthopedic surgery. Intervention 1: Intervention group: BD group is subjected to epidural block with bupivacaine and dexmedetomidine. Intervention 2: Intervention group: BM group are subjected to epidural block with bupivacaine and magnesium sulfate. 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 Still undecided - no release schedule yet
public Reza Akhondzadeh
24 metery street, east sahely highway, ahvaz
Ahvaz Iran (Islamic Republic of) 6193673166 +98 916 113 5201 akhondzadeh-r@ajums.ac.ir Ahvaz University of Medical Sciences scientific Reza Akhondzadeh
24 metery street, east sahely highway, ahvaz
Ahvaz Iran (Islamic Republic of) 6193673166 +98 916 113 5201 akhondzadeh-r@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) 18-60 year old patients with anesthesia risk ASA I,II candidates for lower limb orthopedic surgery 18 years 60 years Both Patients with local infection at the site of epidural block Patients who are allergic to the study drugs Patients who need to receive analgesia during surgery Patients whose epidural block failed and underwent general anesthesia Y83.1 Surgical operation with implant of artificial internal device as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Treatment - Drugs Treatment - Drugs Intervention group: BD group is subjected to epidural block with bupivacaine and dexmedetomidine. Intervention group: BM group are subjected to epidural block with bupivacaine and magnesium sulfate. Pain. Timepoint: After the operation, from the time the level of anesthesia reached T12 to the time of the first application of anesthesia, it was recorded every 30 minutes. Method of measurement: Visual Analogue Scale. Blood pressure. Timepoint: It is recorded immediately after the block and every 5 minutes in the first 30 minutes and every 15 minutes until the end of the sensory and motor block. Method of measurement: Reading from the monitoring device. It is recorded immediately after the block and every 5 minutes in the first 30 minutes and every 15 minutes until the end of the sensory and motor block. Timepoint: It is recorded every 15 minutes until the end of the sensory and motor block. Method of measurement: Reading from the monitoring device. Oxygen Saturation (sat O2). Timepoint: It is recorded immediately after the block and every 5 minutes in the first 30 minutes and every 15 minutes until the end of the sensory and motor block. Method of measurement: Reading from the monitoring device. Length of effect of sensory block. Timepoint: It is measured every 15 minutes. Method of measurement: Until the sensory level reaches L5. Engine block effect length. Timepoint: The first 30 minutes are recorded every 5 minutes and then every 30 minutes until the Modified Bromage Scale number reaches zero. Method of measurement: Time. The first time the medicine is needed after the operation. Timepoint: The first time when the patient needs pain medication after the operation. Method of measurement: Time. Ahvaz University of Medical Sciences Approved 2023-03-14 Ethics Committee of Golestan hospital, Ahvaz Jundishapur University of Medical Sciences Golestan hospital,Golestan Ave,Golestan town Ahvaz Khouzestan Iran (Islamic Republic of)