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IRCT20180724040575N4 IRCT 2020-10-05 Shahid Beheshti University of Medical Sciences Effect of dexmedetomine on delirium Effect of perioperative dexmedetomidine infusion on post operative delirium in on pump heart surgery patients 2019-03-21 anticipated 60 Complete https://irct.ir/trial/50800 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For assignment in intervention and control groups, a simple randomization method with the help of random numbers of Excel software is used. With the help of the RANDBETWEEN function, we create a column consisting of 30 random numbers between 1 and 60, and by removing duplicate items, we continue this function until the complete production of 30 random numbers. These numbers are the row of participants who are in the intervention group, and naturally the row of numbers that are not in this list of 30 are in the control group. For each row of participants, a closed envelope is prepared by the researcher not present in the operating room, and with the arrival of each patient, the relevant envelope is opened by the project partner in the operating room and the designated group is determined, Blinding description: Participants are not aware of the administration of the drug or placebo infused during anesthesia. Data collector are also unaware of the study group. 3 Delirium. Intervention 1: Intervention group: In this group, after induction of anesthesia, dex medetomidine at a dose of 0.2 to 0.5 micrograms per kilogram per hour is started as an intravenous infusion and continues until the sternum closes at the end of the operation. Dexmedetomidine made by Exir Company is used with an initial concentration of 200 micrograms in 2 ml, which is dissolved in 50 ml of normal saline made by Shahid Ghazi serum manufacturing company and will be used with a final concentration of 4 micrograms per ml. syringe Pump and 50 ml syringe are used for infusion. Intervention 2: Control group: In this group, after induction of anesthesia, normal saline serum at a dose of 0.1 ml / kg / h is started as an intravenous infusion and continues until the sternum is closed at the end of the operation. Normal saline is prepared in 50 ml syringe and the infusion is performed by a pump syringe. 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 No other information
public Kamal Fani
Modarres Hospital, Saadat Abad Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2207 4095 kamalfani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Kamal Fani
Modarres Hospital, Saadat Abad Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2207 4095 kamalfani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Adults candidate for cardiac surgery Ejection Fraction(EF) >20% 40 years 80 years Both Known allergy to dexmedetomidine Taking preoperative antipsychotic drugs Lack of patient cooperation and satisfaction History of delirium, neuropsychiatric disorders and seizures Emergency operation F05 Delirium due to known physiological condition Treatment - Drugs Placebo Intervention group: In this group, after induction of anesthesia, dex medetomidine at a dose of 0.2 to 0.5 micrograms per kilogram per hour is started as an intravenous infusion and continues until the sternum closes at the end of the operation. Dexmedetomidine made by Exir Company is used with an initial concentration of 200 micrograms in 2 ml, which is dissolved in 50 ml of normal saline made by Shahid Ghazi serum manufacturing company and will be used with a final concentration of 4 micrograms per ml. syringe Pump and 50 ml syringe are used for infusion. Control group: In this group, after induction of anesthesia, normal saline serum at a dose of 0.1 ml / kg / h is started as an intravenous infusion and continues until the sternum is closed at the end of the operation. Normal saline is prepared in 50 ml syringe and the infusion is performed by a pump syringe. Delirium score based on Richmond Agitation Sedation Scale. Timepoint: Evaluation of delirium based on Richmond score before , 6 and 24 h after surgery. Method of measurement: Richmond Agitation Sedation Scale (RASS). Shahid Beheshti University of Medical Sciences Approved 2019-09-18 Ethics committee of shahid beheshti University of Medical Sciences Taleghani Hospital , Velenjak Ave., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)