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IRCT20170413033408N6 IRCT 2021-03-11 Gorgan University of Medical Sciences Comparison of the effect of ketamine and magnesium sulfate on pain control after spinal surgery. Comparative effect of ketamine and magnesium sulfate on pain control after spine surgery. 2021-02-23 anticipated 72 Complete https://irct.ir/trial/54366 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: How to assign patients to one of the two drug groups will be done based on the permutation block method. A random sequence of letters A and B will be generated in 18 quadruple blocks and will be provided to one of the members of the research team. This member will not interfere in the selection of samples. The letter A belongs to the magnesium sulfate group and the letter B belongs to the ketamine group, Blinding description: Anesthesia induction will be performed by a design-conscious anesthesiologist who will have no role in the process and outcome of the study, and the preparation of pumps that are similar in appearance (size, shape, volume, manufacturer) will be performed by the recovery nurse and the physician in charge will have no information about its contents and will be blinded. 3 Condition 1: Candidate for laminectomy and discectomy and screw and plaque implantation by posterior lumbar and sacral spine CD. Condition 2: Spondylopathies. Intervention 1: Intervention group: Magnesium sulfate 50 mg / kg by infusion with CVE = 5 ml / kg over 20 minutes; Magnesium sulfate 500 mg / hr as an infusion in a pain pump lasts up to 48 hours after surgery. Intervention 2: Intervention group: ketamine 0.5 mg / kg in bolus form immediately after patient positioning and 2 minutes before surgical incision; Ketamine 2.5 µ / kg / hr as an infusion in a pain pump lasts up to 48 hours after surgery. Yes - There is a plan to make this available What will be shared: Information on the main outcome When: Since 2020 To whom: Researchers working in academic institutions Conditions: No manipulation, mentioning the data reference Where to obtain: Seyed Babak Mojaver Aghili, drbabaka35@gmail.com, Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology, Gorgan, Golestan, Iran. How to obtain: sending an email, complete the personal and professional characteristics with documentation Comments:
public Seyed Babak Mojaver Aghili
Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology of Gorgan, Golestan, Iran
Gorgan Iran (Islamic Republic of) 49341-74515 +98 17 3253 8011 drbabaka35@gmail.com Gorgan University of Medical Sciences scientific Seyed Babak Mojaver Aghili
Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology of Gorgan, Golestan, Iran
Gorgan Iran (Islamic Republic of) 49341-74515 +98 17 3253 8011 drbabaka35@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Class 1 or 2 ASA based on the physical condition of the American Anesthesia Association. Subjects in the age range of 18-65 years. Candidate for laminectomy and discectomy and screw and plaque implantation by posterior lumbar and sacral spine CD. 18 years 65 years Both Previous history of lumbosacral surgery. History of schizophrenia and use of antipsychotic drugs. History of calcium channel blockers. History of neuropathy and myopathy. History of kidney damage requires dialysis in the past. Presence of conduction system abnormalities in the ECG taken from the patient. History of ketamine allergy. The length of stay after surgery is less than 48 hours. M96.1 M45-M49 Postlaminectomy syndrome, not elsewhere classified Spondylopathies Treatment - Drugs Treatment - Drugs Intervention group: Magnesium sulfate 50 mg / kg by infusion with CVE = 5 ml / kg over 20 minutes; Magnesium sulfate 500 mg / hr as an infusion in a pain pump lasts up to 48 hours after surgery. Intervention group: ketamine 0.5 mg / kg in bolus form immediately after patient positioning and 2 minutes before surgical incision; Ketamine 2.5 µ / kg / hr as an infusion in a pain pump lasts up to 48 hours after surgery. Postoperative pain score. Timepoint: Pain score since entering recovery,6, 12, 24, 36 and 48 hours after surgery will be measured. Method of measurement: Based on VAS measurement criteria. Postoperative sedation rate. Timepoint: Sedation score since entering recovery,6, 12, 24, 36 and 48 hours after surgery will be measured. Method of measurement: Based on RSS measurement criteria. Hemodynamic changes. Timepoint: The patient's hemodynamic monitoring will be performed from the time of entering the operating room until the end of the operation. Method of measurement: Hemodynamic criteria (heart rate, systolic, diastolic, and mean arterial blood pressure (MABP), arterial oxygen saturation) of the patient will be measured by Saadat monitoring. Gorgan University of Medical Sciences Approved 2021-01-24 Ethics Committee of Golestan University of Medical Sciences Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology of Gorgan, Gorgan, Gorgan Gorgan Golestan Iran (Islamic Republic of)