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IRCT20160430027677N14 IRCT 2019-05-07 Oroumia University of Medical Sciences The effect of dexmedetomidine on emergence agitation after anesthesia with sevoflorane Evaluation the effect of dexmedetomidine on emergence agitation in children undergoing anesthesia with sevoflurane 2019-01-21 anticipated 70 Complete https://irct.ir/trial/38975 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Seventy patients who recruited as eligible population and assigned to one of two groups(35 patients in each group) by using Random Allocation Software 2.0. Group D (Study group) will be received intravenous dexmedetomidine 0.5 microgram per kilogram and Group C (control group) will be received intravenous saline 0.9%, Blinding description: Dose calculation, drug preparation, and administration will be done by attending anesthesiologist who is not involved or have not participated in this trial.after collecting information from the anesthesia residents, the anesthesiologist will be informed of the group each patient will be assigned to. 2-3 بی قراری. Intervention 1: Intervention group: will be received intravenous dexmedetomidine 0.5 microgram per kilogram in 10 minutes after induction of anesthesia. Intervention 2: Control group: will be received intravenous saline 0.9% after induction of general 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 No more information
public Shahryar Sane
Emergrnt Street, Resalat Avenue
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 sanesh@umsu.ac.ir Oroumia University of Medical Sciences scientific Shahryar Sane
Emergrnt Street, Resalat Avenue
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 sanesh@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) 2 to 8 years old American society of Anesthesiology physical status I adenoidectomy alone or both an adenoidectomy and tonsillectomy general anesthesia with sevoflurane 2 years 8 years Both mental retardation or developmental delay neurologic disease history of asthma or the other lung diseases chronic cough, upper respiratory tract infection within 4 weeks of surgery patients with abnormal airway R45.1 Restlessness and agitation Prevention Placebo Intervention group: will be received intravenous dexmedetomidine 0.5 microgram per kilogram in 10 minutes after induction of anesthesia Control group: will be received intravenous saline 0.9% after induction of general anesthesia Agitation. Timepoint: After extubation, leaving the OR, on admission to PACU, 10, 20, and 30 min after arrival in PACU. Method of measurement: four-point scale. Pain. Timepoint: After extubation, leaving the OR, on admission to recovery, 10, 20, and 30 min after arrival in recovery. Method of measurement: face leg activity cry consolability. Mean arterial pressure. Timepoint: Minutes 5, 10, 15 and 20 during surgery. Method of measurement: None invasive barometer pressure. Heart rate. Timepoint: Minutes 5, 10, 15 and 20 during surgery. Method of measurement: Electrocardiogram. Oroumia University of Medical Sciences Approved 2019-01-16 Ethics commitee of Urmia University of Medical Sciences Emergent Street, Ershad Avenue Urmia West Azarbaijan Iran (Islamic Republic of)