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IRCT20180724040575N1 IRCT 2020-09-19 Shahid Beheshti University of Medical Sciences Comparison of the effect of propofol and ketamine on brain oximetry results comparative effect of propofol and ketamine sedation on cerebral oxymetry results in pediatric cardiac catheterisation 2020-09-22 anticipated 44 Complete https://irct.ir/trial/50809 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization by flip the coin method. The allocation of two sides of a coin to each of the study groups was determined and then the number of coin samples was thrown and recorded, Blinding description: Patients and parents and the registrant of the research questionnaire (about used used medication) are blind. All parents have approved the consent form but are not aware of the grouping The anesthesiologist will prescribe a sedative based on the pre-determined group, but the person recording the questionnaire in the cath. lab. control room is not aware of the groups. 3 Diagnostic cardiac catheterization in children. Intervention 1: Intervention group: ketamine(As an anesthetic drug commonly used in sedation of children undergoing the procedure) is administered intravenously at doses of 1 mg per kg with control of vital signs and hemodynamics. The drug is repeated throughout the procedure based on the patient's reactions and the decision of the responsible anesthesiologist. Number of injections, total dose and duration of procedure and patient recovery time are recorded.Ketamine drug produced by Rotex Medica with an initial concentration of 50 mg / ml, which is diluted to 2 mg / ml is used. Intervention 2: Intervention group: propofol (As an anesthetic drug commonly used in sedation of children undergoing the procedure) is administered intravenously at doses of 1 mg per kg with control of vital signs and hemodynamics. The drug is repeated throughout the procedure based on the patient's reactions and the decision of the responsible anesthesiologist. Number of injections, total dose and duration of procedure and patient recovery time are recorded.Baxter 1% propofol is used, which is diluted up to 2 mg per milliter. 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 extra information
public Kamal Fani
Modarres Hosp., Saadat abad Ave.,
Tehran Iran (Islamic Republic of) 19969111151 +98 21 2207 4095 kamalfani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Kamal Fani
Modarres Hosp., Saadat abad Ave.,
Tehran Iran (Islamic Republic of) 19969111151 +98 21 2207 4095 kamalfani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Children referring to the cath lab. of Shahid Modares Hospital for diagnostic cardiac catheterization 6 months 60 months Both Parental dissatisfaction Known allergy to ketamine or propofol History of seizure or other neurological diseases Treatment - Drugs Treatment - Drugs Intervention group: ketamine(As an anesthetic drug commonly used in sedation of children undergoing the procedure) is administered intravenously at doses of 1 mg per kg with control of vital signs and hemodynamics. The drug is repeated throughout the procedure based on the patient's reactions and the decision of the responsible anesthesiologist. Number of injections, total dose and duration of procedure and patient recovery time are recorded.Ketamine drug produced by Rotex Medica with an initial concentration of 50 mg / ml, which is diluted to 2 mg / ml is used. Intervention group: propofol (As an anesthetic drug commonly used in sedation of children undergoing the procedure) is administered intravenously at doses of 1 mg per kg with control of vital signs and hemodynamics. The drug is repeated throughout the procedure based on the patient's reactions and the decision of the responsible anesthesiologist. Number of injections, total dose and duration of procedure and patient recovery time are recorded.Baxter 1% propofol is used, which is diluted up to 2 mg per milliter. Cerebral oximetry number by near infrared spectroscopy. Timepoint: Before and after catheterization every 5 minutes to the end of the procedure and transfer to the recovery room. Method of measurement: Near infrared spectroscopy. Heart beat. Timepoint: 5 minutes. Method of measurement: By pulse oximetry and electrocardiogram monitoring device. Blood oxygen saturation. Timepoint: 5 minutes. Method of measurement: By pulse oximetry device. Blood pressure. Timepoint: 5 minutes. Method of measurement: by non-invasive sphygmomanometer. Shahid Beheshti University of Medical Sciences Approved 2019-12-15 Ethics committee of shahid beheshti University of Medical Sciences Taleghani Hospital, velenjak, Tehran. Iran Tehran Tehran Iran (Islamic Republic of)