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IRCT20190522043672N3 IRCT 2023-02-16 Mashhad University of Medical Sciences Efficacy and safety of two drugs, midazolam and dexmedomidine, in sedation of children Efficacy and safety of two drugs, midazolam, and dexmedetomidine, on the sedation of mechanically ventilated children 2023-02-09 anticipated 124 Complete https://irct.ir/trial/68089 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization sequence generation using www.randomization.com For 124 people, it will be coded A and B, and the allocation will be concealed using a coded and numbered sealed envelope, Blinding description: The plan's statistical consultant who analyzes the data does not have information about the type of drug. 1 Other side effects of anesthesia and sedation. Intervention 1: Intervention group: Dexmedomidine is injected intravenously. The bolus dose of the drug will be 0.5 micrograms per kilogram and the starting dose of the infusion will be 0.25 micrograms per kilogram per hour. While evaluating every 15 minute, if the sedation level is lower than the target level, 0.25 micrograms per kilogram per hour will be added to the drug dose at each turn, up to a maximum of 1 microgram per kilogram per hour. Intervention 2: Control group: Children from 1 month to 15 years who are under mechanical ventilation in the intensive care unit and are injected intravenously with midazolam for sedation. The bolus dose of the drug will be 0.15 mg per kilogram and the starting dose of the infusion will be 1 microgram per kilogram per minute. While evaluating every one hour, if the level of sedation is lower than the target level, 1 microgram per kilogram per minute will be added to the drug dose at each turn, up to a maximum of 4 micrograms per kilogram per minute. If we do not reach the target sedation level with the maximum dose, the treatment will be considered a failure and the second sedative drug will be added. Yes - There is a plan to make this available What will be shared: The main and secondary results can be shared. When: Six months after the results are published To whom: Researchers affiliated with academic centers Conditions: Researchers affiliated with academic centers Where to obtain: Dr.Majid Sezavar How to obtain: Request via email to sezavardm@mums.ac.ir Comments:
public Majid Sezavar
ِakbar hospital.Mashhad University of Medical Sciences, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3870 9225 sezavardm@mums.ac.ir Mashhad University of Medical Sciences scientific Majid Sezavar
Akbar Children's Hospital, Shahid Kaveh 14, Shahid Kaveh Boulevard
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3870 9225 sezavardm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Suffering from dysfunction of the central nervous system, whether genetic or acquired 1 month 18 years Both Having bradycardia Resistant hypotension during treatment T88.5 Other complications of anesthesia Treatment - Drugs Treatment - Drugs Intervention group: Dexmedomidine is injected intravenously. The bolus dose of the drug will be 0.5 micrograms per kilogram and the starting dose of the infusion will be 0.25 micrograms per kilogram per hour. While evaluating every 15 minute, if the sedation level is lower than the target level, 0.25 micrograms per kilogram per hour will be added to the drug dose at each turn, up to a maximum of 1 microgram per kilogram per hour. Control group: Children from 1 month to 15 years who are under mechanical ventilation in the intensive care unit and are injected intravenously with midazolam for sedation. The bolus dose of the drug will be 0.15 mg per kilogram and the starting dose of the infusion will be 1 microgram per kilogram per minute. While evaluating every one hour, if the level of sedation is lower than the target level, 1 microgram per kilogram per minute will be added to the drug dose at each turn, up to a maximum of 4 micrograms per kilogram per minute. If we do not reach the target sedation level with the maximum dose, the treatment will be considered a failure and the second sedative drug will be added The rate of treatment failure and the need for a second sedative drug. Timepoint: The first day, the second day and the third day of the intervention. Method of measurement: Using the Ramsay score table. Duration of reaching target sedation. Timepoint: The first, second and third day of the intervention. Method of measurement: Measuring time with a timer. Duration of mechanical ventilation. Timepoint: The day of the patient's discharge. Method of measurement: patient file. Bradycardia. Timepoint: daily during the intervention period. Method of measurement: Doctor supervision and clinical monitor. Hypotension. Timepoint: daily during the intervention period. Method of measurement: Mercury sphygmomanometer. Mortality rate. Timepoint: The last day of hospitalization. Method of measurement: patient file. Duration of stay in PICU. Timepoint: The day of the patient's discharge. Method of measurement: patient file. Re-evaluation of Ramsay score in successful patients at 6 hour later in follow-up. Timepoint: in follow-up. Method of measurement: Ramsay sedation scale. Mashhad University of Medical Sciences Approved 2023-01-21 Ethics Committee of Mashhad University of Medical Sciences Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)