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IRCT20160307026950N13 IRCT 2019-06-19 Esfahan University of Medical Sciences THE effect of adding Dexmedetomidine on variation in heart rate and blood pressure after anesthesia with Thiopental sodium in electroconvulsive therapy (Ect) A comparative study of the effect of adding Dexmedetomidin on variation in heart rate and blood pressure after the anesthesia by Thiopental sodium in children's Electroconvulsive therapy(ECT) 2018-03-21 anticipated 60 Complete https://irct.ir/trial/39282 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Block Randomization unit: Individual Randomization tool: Random Allocation software Patients are randomly assigned to intervention and control groups using the Random Allocation computer software, Blinding description: The drugs are prepared in one form and in the same volume in the syringe by the researcher and the hemodynamic changes are monitored and recorded so the attending and the clinical caregiver and the evaluator and data analyser do not understand the type of medication and the investigator deciphers the codes after dara analysis. 3 Condition 1: Blood pressure. Condition 2: Heart rate. Intervention 1: Intervention group: Initially,personal consent is obtained from the parents of patients.Then the patient is placed on the operating bed and standard monitoring devices including :pulsoximetry ,capnography and electrocardiogram are attached.In this group Dexmedetomidin 0/2 mcg/kg is injected. Intervention 2: Control group: Initially,personal consent is obtained from the parents of patients.Then the patient is placed on the operating bed and standard monitoring devices including :pulsoximetry ,capnography and electrocardiogram are attached. In this group patients are injected from a syringe filled with Normal salin. 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 Mahtab Nourbakhsh
Unit 112, Negin-abshar Building ,Rezvan Alley , First Abshar Street
Isfahan Iran (Islamic Republic of) 81656-63997 +98 31 3662 5060 mahtabnourbakhsh@yahoo.com Esfahan University of Medical Sciences scientific Behzad Nazemroaya
Hezarjarib Street
Isfaan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients younger than 25 years old Patients with American society of anesthesiology physical status class 1,2 (ASA 1,ASA2) Patients candidate receiving electroconvulsive therapy Patients with satisfaction to participate in study no limit 25 years Both Patients with allergies to the drugs studied R03.0 R00.0 Elevated blood-pressure reading, without diagnosis of hypertension Tachycardia, unspecified Treatment - Drugs Placebo Intervention group: Initially,personal consent is obtained from the parents of patients.Then the patient is placed on the operating bed and standard monitoring devices including :pulsoximetry ,capnography and electrocardiogram are attached.In this group Dexmedetomidin 0/2 mcg/kg is injected. Control group: Initially,personal consent is obtained from the parents of patients.Then the patient is placed on the operating bed and standard monitoring devices including :pulsoximetry ,capnography and electrocardiogram are attached. In this group patients are injected from a syringe filled with Normal salin. Heart rate changes. Timepoint: Before the intervention,during the seizure ,1,5,10 minutes after end of seizure. Method of measurement: Heart monitoring. Mean arterial pressure. Timepoint: Before the intervention,during seizure,1,5,10 minutes after end of seizure. Method of measurement: Non invasive blood pressure monitor. Systolic blood pressure. Timepoint: Before the intervention , during seizure , 1,5,10 minutes after end of siezure. Method of measurement: Non invasive blood pressure monitor. Diastolic blood pressure. Timepoint: Before the intervention , during seizure , 1,5,10 minutes after end of seizure. Method of measurement: N on invasive blood pressure monitor. Oxygen saturation. Timepoint: Before intervention ,during seizure , 1,5,10 minutes after end of seizure. Method of measurement: Percent with pulse oximeter. Duration of seizure. Timepoint: After intervention. Method of measurement: In second using a chornometer. Recovery time. Timepoint: From the end of seizure to full consciousness. Method of measurement: Minute with using a chornometer. Back up self breathing time. Timepoint: From the end of seizure until back up self breathing. Method of measurement: Seconds with using a chronometer. Nausea and Vomiting. Timepoint: After end of the seizure. Method of measurement: Questionnaire. Laryngospasm. Timepoint: After end of the seizure. Method of measurement: Evaluation of respiration and oxygen saturation. Headache. Timepoint: After the end of seizure. Method of measurement: Questionnaire. Esfahan University of Medical Sciences Approved 2018-02-09 Ethics committee of Isfahan University of Medical Sciences Hezar jarib street Isfahan Isfehan Iran (Islamic Republic of)