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IRCT20161022030421N4 IRCT 2019-07-16 Bagheiat-allah University of Medical Sciences The effect of Dexmedetomidin infusion in the intensive care unit Clinical trial comparing the sedative effect of Dexmedetomidin infusion versus placebo in the intensive care unit on patients undergoing open heart surgery under cardiopulmonary bypass pump. 2019-07-11 anticipated 60 Complete https://irct.ir/trial/37914 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Randomization was stratified using a random table number, Blinding description: The medication or placebo is prepared and coded by the co-worker in a 50cc syringe. Each cc of the solution in the syringe contains four micrograms of Dexmedetomidine or a placebo. The patient and the researcher and the specialist nurses will not be informed of the prepared syringe's contents. Researcher will be injected into a patient for 10 minutes from a randomized encoded syringe, equivalent to 1 μg / kg Dexmedetomidine and then the medicine will be infused In a volume equivalent to 0.2 to 0.7 micrograms per kilogram, in accordance with the patient's needs. Upon completion of the sampling, the co-worker will provide the information about the coding of the syringes. 3 Patients undergoing heart surgery with CPP pump.. Intervention 1: Intervention group: Dexmedetomidine is infused at a dose of 1 μg / kg for 10 minutes and the patient is transferred to the ICU and placed under mechanical ventilation. In ICU, a low dose infusion of 0.2 μg / kg of infusion begins, and, according to the patient's need, the dosage of the drug increases to 0.7 μg / kg for the purpose of achieving Richmond agitation-sedation scale 1-2 + 1. After the extubation condition, the patient is extubated and the dosage of Dexmedetomidine is continued with the aim of achieving RASS 0  (calm and alert). Intervention 2: Control group: after the completion of surgery, placebo (normal saline) is infused over 10 minutes (due to the blindness of the study), and the patient is transferred to the ICU and placed under mechanical ventilation. ICU will find a placebo infusion. In this group, the purpose of sedation is until the patient is mechanically ventilated by RASS -2_ + 1 and after extruding RASS 0. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: starting 1 months after publication To whom: people working in academic institutions Conditions: for meta analysis Where to obtain: from Email How to obtain: By sending a request to the university Vice-Dean for Research and obtaining a license Comments:
public Marzieh Lak
Baqiyatallah University of Medical Science, Mollasadra Street, Sheikhbahai Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435915371 +98 212449013 marziehlak@bmsu.ac.ir Bagheiat-allah University of Medical Sciences scientific Marzieh Lak
Baqiyatallah University of Medical Science, Mollasadra Street, Sheikhebahahi Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435915371 +98 212449013 marziehlak@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients referred for coronary artery bypass grafting after obtaining informed consent no limit no limit Both Emergency patients Has a history of liver disease, kidney disease, heart block grade 2 or 3 Systolic blood pressure below 90 mmHg History of psychological disease Use of psychological drugs Opioid addiction Re- surgery I25.1 Atherosclerotic heart disease of native coronary artery Treatment - Drugs Placebo Intervention group: Dexmedetomidine is infused at a dose of 1 μg / kg for 10 minutes and the patient is transferred to the ICU and placed under mechanical ventilation. In ICU, a low dose infusion of 0.2 μg / kg of infusion begins, and, according to the patient's need, the dosage of the drug increases to 0.7 μg / kg for the purpose of achieving Richmond agitation-sedation scale 1-2 + 1. After the extubation condition, the patient is extubated and the dosage of Dexmedetomidine is continued with the aim of achieving RASS 0  (calm and alert). Control group: after the completion of surgery, placebo (normal saline) is infused over 10 minutes (due to the blindness of the study), and the patient is transferred to the ICU and placed under mechanical ventilation. ICU will find a placebo infusion. In this group, the purpose of sedation is until the patient is mechanically ventilated by RASS -2_ + 1 and after extruding RASS 0. Incidence of delirium. Timepoint: From the arrival of the patient to the intensive care unit until the patient's discharge from the intensive care unit, the nurse will be evaluated in each shift. Method of measurement: Confusion assessment method for the ICU (CAM-ICU ). Duration of stay in the intensive care unit. Timepoint: From the arrival of the patient to the intensive care unit until the discharge of the patient from the intensive care unit is evaluated by the unit of the day. Method of measurement: From the arrival of the patient to the intensive care unit until the discharge of the patient from the intensive care unit is evaluated by the unit of the day. Duration of mechanical ventilation. Timepoint: From the patient's arrival to the intensive care unit until the tracheal tube is removed, in hours. Method of measurement: From the patient's arrival to the intensive care unit until the tracheal tube is removed, in hours. Reducing the dose required by morphine and midazolam to achieve desired urination. Timepoint: The patient's arrival in the intensive care unit until the patient's discharge from the intensive care unit is calculated in milligrams. Method of measurement: The patient's arrival in the intensive care unit until the patient's discharge from the intensive care unit is calculated in milligrams. Incidence of arrhythmia. Timepoint: From the patient's entrance to the intensive care unit until the discharge of the patient from the intensive care unit is assessed by continuous monitoring of electrocardiogram by a specialist nurse. Method of measurement: From the patient's entrance to the intensive care unit until the discharge of the patient from the intensive care unit is assessed by continuous monitoring of electrochardiogram by a specialist nurse. Assessment of Nurses' satisfaction in ICU. Timepoint: During the period of hospital stay in the intensive care unit by three specialist nurses, using VAS score. Method of measurement: During the period of hospital stay in the intensive care unit by three specialist nurses, using VAS score. Changes in blood pressure. Timepoint: From the beginning of the patient's arrival in the intensive care unit until the first six hours, blood pressure was recorded every hour.Then from the sixth hour until the discharge of the patient from the intensive care unit was recorded every 3 hours. Method of measurement: From the beginning of the patient's arrival in the intensive care unit until the first six hours, blood pressure was recorded every hour.Then from the sixth hour until the discharge of the patient from the intensive care unit was recorded every 3 hours. Heart rate. Timepoint: From the beginning of the patient's arrival in the intensive care unit until the discharge of the patient from the intensive care unit, heart rate was continuously monitored and recorded. Method of measurement: From the beginning of the patient's arrival in the intensive care unit until the discharge of the patient from the intensive care unit, heart rate was continuously monitored and recorded. Bagheiat-allah University of Medical Sciences Approved 2019-06-25 Ethics Committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Science, Mollasadra Street, Sheikh Bahaee Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)