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IRCT20160307026950N29 IRCT 2020-12-21 Esfahan University of Medical Sciences The effect of Dexmedetomidine in pediatric Electroconvulsive therapy ETC نام اختصاری Electro Convulsive Therapy میباشد. The investigation of the effect of adding Dexmedetomidine to Propofol on changes in heart rate and blood pressure in pediatric Electroconvulsive therapy 2020-12-30 anticipated 70 Complete https://irct.ir/trial/53045 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: In this study, awareness and consent of patients' parents is obtained, Randomization description: Randomization is done by block method; In this way, the first patient enters one of the groups by drawing lots, then from the second patient, the patients enter the two groups one by one, so that their number in each group reaches 35 people, Blinding description: This is a double-blind study; As the clinical caregiver is different from the person injecting the drug and is unaware of the type of intervention, patients are also unaware of the type of intervention applied and are therefore blind. 3 Condition 1: Blood Pressure. Condition 2: Heart Rate. Intervention 1: Intervention group A: Patients in this group after lying on the bed and monitoring connection with 0.5 mg per kg body weight SuccinylCholine, 2 mg per kg body weight Thiopental and 1 mg Propofol per kg body weight and then 0.5 mg / kg Dexmedetomidine is anesthetized and Electroconvulsive therapy is initiated. Patients are recorded during ECT until the end of monitor recovery and changes in vital signs. Intervention 2: Control group B: Patients in this group after lying on the bed and monitoring connection with 0.5 mg per kg body weight Succinylcholine, 2 mg per kg body weight Thiopental and 1 mg Propofol per kg body weight and then 0.5 ml of normal saline is anesthetized and Electroconvulsive therapy is initiated. Patients are recorded during ECT until the end of monitor recovery and changes in vital signs. 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 There is no more information
public Dorna Masaely
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 m_dorna@yahoo Esfahan University of Medical Sciences scientific Esfahan University of Medical Sciences
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Children 4 to 16 years Candidate for ETC ASA Class I & II 4 years 16 years Both Patients with a history of seizures, Heart failure, Kidney failure, Liver failure, Respiratory failure History of allergy to the studied drugs Addiction to psychotropic substances History of egg allergy R03.0 R00.0 Elevated blood-pressure reading, without diagnosis of hypertension Tachycardia, unspecified Prevention Placebo Intervention group A: Patients in this group after lying on the bed and monitoring connection with 0.5 mg per kg body weight SuccinylCholine, 2 mg per kg body weight Thiopental and 1 mg Propofol per kg body weight and then 0.5 mg / kg Dexmedetomidine is anesthetized and Electroconvulsive therapy is initiated. Patients are recorded during ECT until the end of monitor recovery and changes in vital signs. Control group B: Patients in this group after lying on the bed and monitoring connection with 0.5 mg per kg body weight Succinylcholine, 2 mg per kg body weight Thiopental and 1 mg Propofol per kg body weight and then 0.5 ml of normal saline is anesthetized and Electroconvulsive therapy is initiated. Patients are recorded during ECT until the end of monitor recovery and changes in vital signs. Heart Rate. Timepoint: Before drug injection and 1, 2, 3, 5 and 10 minutes after anesthesia. Method of measurement: ECG. Blood Pressure. Timepoint: Before drug injection and 1, 2, 3, 5 and 10 minutes after anesthesia. Method of measurement: Manometer. Duration of anesthesia. Timepoint: From the beginning of anesthesia to the end of recovery. Method of measurement: Timer. Duration of seizures. Timepoint: From the moment of the beginning of contractions until the time of relaxation. Method of measurement: Timer. Vice Chancellor for Research, Isfahan University of Medical Sciences Approved 2020-03-01 Isfahan University of Medical Sciences Committe for Ethics in Biomedical Research Hezar Jarib St Isfahan Isfehan Iran (Islamic Republic of)