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IRCT20210904052371N3 IRCT 2022-06-20 Mazandaran University of Medical Sciences Comparison of The Efficacy And Side Effects of Combined Doses of Dexmedetomidine And Propofol With Isoflurane And Nitrosoxide as a General Anesthetic Preservative in Orthopedic Surgeries Comparison of The Efficacy And Side Effects of Combined Doses of Dexmedetomidine And Propofol With Isoflurane And Nitrosoxide as a General Anesthetic Preservative in Orthopedic Surgeries 2022-06-22 anticipated 90 Complete https://irct.ir/trial/64092 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients who meet the inclusion criteria are randomly assigned (using a table of random numbers) to three groups A, B and C (30 people in each group). The anesthesia assistant will not know the study groups and the dose of IV and inhaled drugs. The drugs will be prepared by an anesthesiologist using labels A, B and C. They will be provided to the anesthesia assistant in the lower year. B Patients will undergo complete intravenous anesthesia using the maximum combined dose of propofol and dexmedetomidine. In group C, patients will undergo inhalation anesthesia using isoflurane and nitrous oxide, Blinding description: The present study will be conducted in a double-blind method, so that neither patients nor the evaluators of the study outcomes are aware of the placement of patients in the study groups. In addition, fair people are placed in groups. Syringes prepared with different concentrations that have reached the same volumes with normal saline for bolus injection and Prepared microstructures with different concentrations (2 groups of maximum and minimum dose) that have reached the same volumes with normal saline, for infusion during operation A low-year resident or anesthesiologist present at the patient's bedside who do not know the concentration of the drug And record only clinical signs and vital signs. 3 Depth of anesthesia. Intervention 1: Intervention group: Group (A) for dexmedetomidine will use an initial bolus dose (0.5 μg / kg) over 10 minutes and a maintenance dose (0.5 μg / kg / h). Propofol will also be used in bolus dose (0.25 mg / kg) and maintenance dose (0.25 mg / kg / h). Propofol ampoule from Dongkook Pharaceutical COtd-company Korea and dexmedetomidine ampoules EXIR manufacturer Iran. Intervention 2: Intervention group: Group (B) for dexmedetomidine will use an initial bolus dose (1 μg / kg) over 10 minutes and a maintenance dose (1 μg / kg / h). Propofol will also be used in bolus dose (1.5 mg / kg) and maintenance dose (5 mg / kg / h). In each of these groups, dexmedetomidine and propofol are combined and given to the patient. Intervention 3: Control group: To maintain anesthesia, only N2O 50% anesthetics and MAC isoflurane 1 will be used. N2O gas capsule made in Iran and Bethlehem company and isoflurane solution made in USA and from Piramel Critical care company, INC. 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 Goli Azzi
Amir Mazandarani St. Imam Khomeini Hospital
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 Gaezi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Goli Azzi
Amir Mazandarani St. Imam Khomeini Hospital
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 Gaezi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) The patient's desire to participate in the study and gain informed consent Candidate for non-emergency orthopedic surgery under general anesthesia Age between 18-60 years Class 1 and 2 Anesthesia (ASA) Patients who do not have complications such as hypotension, hypertension, bradycardia, pneumothorax, air embolism and decreased arterial oxygen saturation, which is a possible side effect of anesthetics 18 years 60 years Both Emergency surgery Known allergies to the drugs used in the present study Operation longer than 5 hours Patients during the intervention if acute complications such as hypotension, hypertension, bradycardia, pneumothorax, air embolism and a decrease in arterial oxygen saturation. Y84 Other medical procedures 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 Diagnosis Intervention group: Group (A) for dexmedetomidine will use an initial bolus dose (0.5 μg / kg) over 10 minutes and a maintenance dose (0.5 μg / kg / h). Propofol will also be used in bolus dose (0.25 mg / kg) and maintenance dose (0.25 mg / kg / h). Propofol ampoule from Dongkook Pharaceutical COtd-company Korea and dexmedetomidine ampoules EXIR manufacturer Iran Intervention group: Group (B) for dexmedetomidine will use an initial bolus dose (1 μg / kg) over 10 minutes and a maintenance dose (1 μg / kg / h). Propofol will also be used in bolus dose (1.5 mg / kg) and maintenance dose (5 mg / kg / h). In each of these groups, dexmedetomidine and propofol are combined and given to the patient. Control group: To maintain anesthesia, only N2O 50% anesthetics and MAC isoflurane 1 will be used. N2O gas capsule made in Iran and Bethlehem company and isoflurane solution made in USA and from Piramel Critical care company, INC Time to wake up from anesthesia. Timepoint: From the moment of closing the anesthetic (inhaled or intravenous) to the moment of waking the patient if the patient is able to obey instructions and communicate. Method of measurement: Visual Analogue Scale. Depth of anesthesia. Timepoint: Immediately before and after induction (before starting maintenance dose), while receiving maintenance dose, when discontinuing anesthesia, moment of awakening from anesthesia, end of recovery. Method of measurement: brain function assessment. Mazandaran University of Medical Sciences Approved 2022-04-13 Ethics Committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)