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IRCT20200225046610N1 IRCT 2020-12-15 Ahvaz University of Medical Sciences The comparison effect of dexmedetomidine and propofol during laparoscopic cholecystectomy The comparison effect of dexmedetomidine and propofol on hemodynamics parameters and stress response hormones during laparoscopic cholecystectomy in patients referred to Razi Hospital in 2019-2020 2020-03-20 anticipated 70 Complete https://irct.ir/trial/50345 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Due to two group of study, randomization is simple method. According being to odd or even of last number of case file number, Patient will divided to one of group, Blinding description: All participants in this study, which include two intervention groups one and two, will be given the necessary drug information and will participate in the project with full knowledge, but do not know which group they are in. The main researcher of the project define A and B group that second physician (Anesthetist resident) and statistician dose not any knowledge type of drug in grouping. 2-3 laparoscopic cholecystectomy patients. Intervention 1: intervention group 1: To induce anesthesia in both groups, a combination of midazolam (Caspian CO.)(0.05 mg / kg), fentanyl (Caspian CO.) (2 μg / kg), thiopental sodium (VUAB pharma CO.) (4 mg / kg), and atracurium (Caspian CO.) (0.5 Mg / kg) will be used intravenously.The propofol group, propofol (Fresenius CO.) (75 μg / kg/min) and atracurium (Caspian CO.) (0.1 mg/kg) will be used intravenously and alternately every 20 minutes as a relaxant to maintain anesthesia. Intervention 2: intervention group 2: Induction of anesthesia will be the same as the previous group. Dexmedetomidine will be given immediately after induction with dexmedetomidine (Exir CO) at a bolus dose of 1 µg /kg. for maintenance of Anesthesia propofol (Fresenius CO.) (75 μg/kg/min) and atracurium (Caspian CO.) (0.1 mg/kg) will be used intravenously and alternately every 20 minutes as a relaxant to maintain anesthesia. 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 Farzad Khalvati
Ahvaz Jundishapur University of Medical Sciences, Golestan St. , Ahvaz , Iran.
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 6475 9841 khalvatifarzad@gmail.com Ahvaz University of Medical Sciences scientific Ali Ghomeishi
Ahvaz Jundishapur University of Medical Sciences, Golestan St. , Ahvaz , Iran.
ahvaz Iran (Islamic Republic of) 6135715794 +98 61 6475 9841 ghomeishi-a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) The patients between 20 to 60 age years old The candidate patients for laparoscopic cholecystectomy 20 years 60 years Both The patients have class II or III obesity Chronic liver disease Diabetes Kidney disease Endocrine problems Romatoid disease The cardiovascular disease patients which use a beta-blocker drug that affects sympathies response and hormonal secretion and finally The person uses benzo diazepines are excluded from this study K80.40 Calculus of bile duct with cholecystitis, unspecified, without obstruction Treatment - Drugs Treatment - Drugs intervention group 1: To induce anesthesia in both groups, a combination of midazolam (Caspian CO.)(0.05 mg / kg), fentanyl (Caspian CO.) (2 μg / kg), thiopental sodium (VUAB pharma CO.) (4 mg / kg), and atracurium (Caspian CO.) (0.5 Mg / kg) will be used intravenously.The propofol group, propofol (Fresenius CO.) (75 μg / kg/min) and atracurium (Caspian CO.) (0.1 mg/kg) will be used intravenously and alternately every 20 minutes as a relaxant to maintain anesthesia. intervention group 2: Induction of anesthesia will be the same as the previous group. Dexmedetomidine will be given immediately after induction with dexmedetomidine (Exir CO) at a bolus dose of 1 µg /kg. for maintenance of Anesthesia propofol (Fresenius CO.) (75 μg/kg/min) and atracurium (Caspian CO.) (0.1 mg/kg) will be used intravenously and alternately every 20 minutes as a relaxant to maintain anesthesia. Heart rate. Timepoint: At the beginning and end of the study. Method of measurement: Anesthesia Monitoring system. Mean atrial blood pressure (MAP). Timepoint: At the beginning and end of the study. Method of measurement: Anesthesia Monitoring system. Duration of anesthesia. Timepoint: At the beginning and end of the study. Method of measurement: Extraction of patient anesthesia sheet. Plasma level of blood sugar. Timepoint: At the beginning and end of the study. Method of measurement: Lab by specto-photometery method. Level of stress hormone (epinephrine, nor-epinephrine, cortisol). Timepoint: At the beginning and end of the study. Method of measurement: Lab by ELISA method. Post operative nausea and vomiting (PONV). Timepoint: After release of recovery room each 6 Hr. Method of measurement: Sensation of nausea and vomiting by Visual Analogue Scale. Ahvaz University of Medical Sciences Approved 2020-01-18 Ethics committee of Ahvaz jundishapour University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan St. , Ahvaz , Iran. Ahvaz Khouzestan Iran (Islamic Republic of)