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IRCT20230530058342N1 IRCT 2023-10-05 Ahvaz University of Medical Sciences The effect of regional analgesia with dexamethasone and dexmedetomidine Comparison of the effect of regional analgesia with dexamethasone and dexmedetomidine on spinal surgery 2023-11-06 anticipated 120 Complete https://irct.ir/trial/72933 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Entered patients will be randomly divided into three groups with a ratio of 1:1:1 using a table of random numbers generated by the computer. The distribution results will be sealed in a sealed envelope and kept by the research manager. On the day of the procedure, the principal reasercher will hand over the envelope to the anesthesia assistant to prepare the test fluid. In fact, the patients and the anesthesia assistant will be blinded to the type of used adjuvant (Dexmedetomidine or Dexamethasone or placebo), Blinding description: Entered patients will be randomly divided into three groups with a ratio of 1:1:1 using a table of random numbers generated by the computer. The distribution results will be sealed in a sealed envelope and kept by the research manager. On the day of the procedure, the principal reasercher will hand over the envelope to the anesthesia assistant to prepare the test fluid. In fact, the patients and the anesthesia assistant will be blinded to the type of used adjuvant (Dexmedetomidine or Dexamethasone or placebo). 3 Postoperative Pain after discopathy surgery. Intervention 1: Intervention group 1: For the dexamethasone group, 0.2 mg/kg of dexamethasone is placed inside the gelophane on the operation site before suturing the operation site. Each ampule of dexamethasone contains 8 mg and belongs to Alborz Daru Company. Intervention 2: Intervention group 2: For the dexmedetomidine group, 0.2mg/kg of dexmedetomidine is placed inside the gelophane on the operation site before suturing the operation site. Each vial of dexmedetomidine contains 2 cc (200 micrograms) and belongs to Elixir company. Intervention 3: Control group: For the control group, normal saline with gelophane is placed in the operation site before suturing the operation site. 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 Mahshid Vaziri
Ahvaz Golestan Hospital, Golestan
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3037 vaziri-m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mahshid Vaziri
Ahvaz Golestan Hospital, Golestan
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3037 vaziri-m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) All patients who are going to undergo posterior 1 or 2 lumbar spine surgery at ASA I-II level 16 years 65 years Both History of oversensitivity to Dexamethasone History of oversensitivity to Dexmedetomidine History of severe Cardiac disease History of severe Pulmonary disease History or presence of arrhythmias Kidney failure Liver failure Pcychiatric disorder History of chronic pain Addiction to opioids History of longterm use of sedative medications G89.18 Other acute postprocedural pain Rehabilitation Rehabilitation Rehabilitation Intervention group 1: For the dexamethasone group, 0.2 mg/kg of dexamethasone is placed inside the gelophane on the operation site before suturing the operation site. Each ampule of dexamethasone contains 8 mg and belongs to Alborz Daru Company. Intervention group 2: For the dexmedetomidine group, 0.2mg/kg of dexmedetomidine is placed inside the gelophane on the operation site before suturing the operation site. Each vial of dexmedetomidine contains 2 cc (200 micrograms) and belongs to Elixir company. Control group: For the control group, normal saline with gelophane is placed in the operation site before suturing the operation site. Pain level based on VAS 10 scale. Timepoint: Postoperative pain will be assessed every 30 minutes for the first 2 hours and then every 2 hours up to 24 hours using a 10 cm VAS. Method of measurement: VAS 10 Scale. The time that the first pain killer is requested by the patient. Timepoint: As soon as the first painkiller is requested by the patient. Method of measurement: Based on the time that the first pain killer is requested by the patient. The total amount of narcotics consumed by the patient in the first 24 hours after the operation. Timepoint: Every 30 minutes for the first 2 hours and then every 2 hours for 24 hours. Method of measurement: Based on the amount of narcotics consumed based on milligrams. Ahvaz University of Medical Sciences Approved 2023-03-14 Ethics committee of Golestan Hospital at Ahvaz University of Medical Sciences Golestan Hospital, Golestan Ahvaz Khouzestan Iran (Islamic Republic of)