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IRCT20170413033408N3 IRCT 2020-06-11 Gorgan University of Medical Sciences Comparison of the effect of drug combination in lower back anesthesia on duration of effect and changes in heart rate and blood pressure in patients undergoing orthopedic surgery with lower limb fractures Comparison the effect of combined of (bupivacaine + magnesium sulfate) with combined (pethidine + magnesium sulfate) and sole pethidine in spinal anesthesia on effect of duration and hemodynamic changes in patients under Lower Limb orthopedic surgery 2020-08-20 anticipated 120 Complete https://irct.ir/trial/47154 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting the participants who have the conditions to enter the study, using the random blocks method, these people will be assigned to four groups A, B, C, D. According to the sample size of 30 in the groups, all four blocks of letters A, B, C and D are considered and thirty blocks will be randomly selected; In a random process, a sequence of one hundred and twenty letters A, B, C, D will be created, then this sequence will be numbered from one to 120 numbers. Numbers one to 120 will be placed in a bag, and the researcher will randomly select one of the numbers for each eligible person in the present study, based on the selected number in one of the letters A, B, C, D (respectively to Combination groups (Bupivacaine + Magnesium Sulfate), Combination ( Pethdine + Magnesium Sulfate), Pethdine and Bupivacaine will be done, Blinding description: In this study, in order to perform the method of blinding the patient, the statistical evaluator and analyst will not be aware of the type of groups. 3 Lower Limb fracture. Intervention 1: Intervention group: Group A patients will receive Intrathecal magnesium sulfate with 100 mg bupivacaine at a dose of 10 mg. Intervention 2: Intervention group: Group B will be patients receiving 100 mg of Intrathecal magnesium sulfate with pethidine at a dose of 1 mg / kg . Intervention 3: Intervention group: group C Petdin 1 mg / kg will be injected into the spinal cord. Intervention 4: Control group: Group D Bupivacaine will be injected Intrathecal at a dose of 10 mg. Yes - There is a plan to make this available What will be shared: Information on the main outcome When: Since 2021 To whom: Researchers working in academic institutions Conditions: No manipulation, mentioning the data reference Where to obtain: Seyed Babak Mojaver Aghili, drbabaka35@gmail.com, Golestan University of Medical Sciences, Deputy of Research and Technology, Gorgan, Golestan, Iran, Gorgan, 4 km, Sari, How to obtain: sending an email, complete the personal and professional characteristics with documentation Comments:
public dr Babak Mojaver Aghilli
Golestan University of Medical Sciences.School of Medicine, Department of Anesthesiology, Gorgan, Shastkola road
Gorgan Iran (Islamic Republic of) 4917763681 +98 17 3115 3566 drbabaka35@gmail.com Gorgan University of Medical Sciences scientific Seyed babak Mojaveraghili
Medical school, anesthesia group, Gorgan - Sari 4th kilometers
Gorgan Iran (Islamic Republic of) 491776381 +98 17 3115 2566 dr.mojaveraghili@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) Patient with lower limb fracture candidate for orthopedic surgery which can be performed under spinal anesthesia Signing a consent form Class 1 or 2 of the physical condition of the American Anesthesia Association ASA Age range 18-60 years Elective surgery 18 years 60 years Both High intracranial pressure Infection in site of injection Impossible of proper position History of allergy with bupivacaine or pethidine M89.9 Disorder of bone, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Group A patients will receive Intrathecal magnesium sulfate with 100 mg bupivacaine at a dose of 10 mg. Intervention group: Group B will be patients receiving 100 mg of Intrathecal magnesium sulfate with pethidine at a dose of 1 mg / kg . Intervention group: group C Petdin 1 mg / kg will be injected into the spinal cord Control group: Group D Bupivacaine will be injected Intrathecal at a dose of 10 mg. The duration of the anesthetic effect. Timepoint: The duration of anesthesia will be recorded every minute immediately after intravenous injection until the onset of sensory block and every 5 minutes until sensory level stabilization. Method of measurement: Using a blunt needle and register in the checklist. Hemodynamic change. Timepoint: Hemodynamic changes in the operating room will be measured every 5 minutes until the end of the first 30 minutes, then every 15 minutes until the end of surgery. The recovery room will record every 15 minutes until recovery criteria are met. 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 2020-03-18 Golestan University of Medical Sciences Ethics Committee Gorgan-sari road 4th kilometer,Golestan University of Medical Science Gorgan Golestan Iran (Islamic Republic of)