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IRCT20230828059291N1 IRCT 2023-09-09 Babol University of Medical Sciences comparison of dexmedetomidine and propofol sedation in ICU Comparison of dexmedetomidine and propofol for sedation in patients requiring mechanical ventilation in ICU: A randomized clinical trial 2023-09-14 anticipated 70 Complete https://irct.ir/trial/72320 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is Permuted Block Randomization, which is set as blocks of 4 (AABB). Then, using Excel software, a number is randomly assigned to each of the letters in the block, and then the letters A and B are arranged based on the size of the number that came randomly and form a random sequence, Blinding description: The list of random allocation of patients will only be available to the ICU nurse. In order to hide the random assignment process, random codes are written on the paper label without a specific order and frame, which is the identification number of the relevant treatment, and the list will be available only to the ICU nurse. The labels will be stuck on the medicine packages in the order of the randomization list. Medicine packages will be arranged in the order of the randomization list inside the box. When the doctor declares the eligibility of a patient, the nurse will provide the patient with the treatment package. The person evaluating the intended outcomes is a third person who is unaware of the randomization process and the type of treatment performed. In order to analyze the data, a statistician who is separate from the study process and is unaware of all the processes will be used. 3 Sedation in ICU patients. Intervention 1: Intervention group 1: Group A will receive ِDexmedetomidine with a loading dose of 1 µg/kg for 10 minutes followed by a maintenance infusion of 5 µg/kg/hr (0.2-0.7 µg/kg/hr). If the target level of RSS (4 and 5 ) was not obtained or maintained; A propofol bolus of 0.2 mg/kg will be injected for a maximum of three consecutive boluses at an interval of 3 to 5 minutes. Intervention 2: Intervention group 2: Group B will receive Propofol with an infusion of 2 mg/kg/hr (1-3 mg/kg/hr). If the target level of RSS (4 and 5) is not achieved or maintained; A propofol bolus of 0.2 mg/kg will be injected for a maximum of three consecutive boluses at an interval of 3 to 5 minutes. 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 The release schedule is unknown.
public Amir Hossein Saadati
Motahari st, Andishe 16 alley, 4714957197
Babol Iran (Islamic Republic of) 4714957197 +98 911 754 2722 Asaadati1997@gmail.com Babol University of Medical Sciences scientific Amir Hossein Saadati
Motahari st, Andishe 16 alley, 4714957197
Babol Iran (Islamic Republic of) 4714957197 +98 911 754 2722 Asaadati1997@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) patients over 18 years old staying in ICU for at least 24 hours after surgery need to be intubated and be sedated 18 years no limit Both Hypotension (SBP<90) pregnant women obesity (body weight more than 50% higher than ideal body weight) ESRD patients Glasgow Coma Scale (GCS) below 12 (moderate and severe brain damage) Significant arrhythmia or high degree of atrioventricular node block patients who are allergic to the drugs Treatment - Drugs Treatment - Surgery Intervention group 1: Group A will receive ِDexmedetomidine with a loading dose of 1 µg/kg for 10 minutes followed by a maintenance infusion of 5 µg/kg/hr (0.2-0.7 µg/kg/hr). If the target level of RSS (4 and 5 ) was not obtained or maintained; A propofol bolus of 0.2 mg/kg will be injected for a maximum of three consecutive boluses at an interval of 3 to 5 minutes. Intervention group 2: Group B will receive Propofol with an infusion of 2 mg/kg/hr (1-3 mg/kg/hr). If the target level of RSS (4 and 5) is not achieved or maintained; A propofol bolus of 0.2 mg/kg will be injected for a maximum of three consecutive boluses at an interval of 3 to 5 minutes. Comparison of the need for narcotic drug (fentanyl) in dexmedetomidine and propofol groups. Timepoint: The amount of injected fentanyl will be measured at the end of 24 hours. Method of measurement: The amount of fentanyl injection will be recorded during the study. Hemodynamic parameters (systolic and diastolic blood pressure, heart rate, mean arterial blood pressure). Timepoint: Hemodynamic parameters will be recorded at intervals of 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours and 24 hours. Method of measurement: The monitoring device. Respiratory parameters (respiratory rate, spontaneous breathing and airway pressure). Timepoint: Respiratory parameters will be recorded at intervals of 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours and 24 hours. Method of measurement: The mentioned variables are measured by ventilator devices and then recorded at the time intervals. Level of consciousness. Timepoint: The level of consciousness will be recorded at intervals of 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours and 24 hours. Method of measurement: The level of consciousness will be measured by Ramsay Sedation Scale. Babol University of Medical Sciences Approved 2023-08-27 Ethics committee of Babol University of Medical Sciences Ganjafrooz Street, Babol University of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)