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IRCT20160307026950N14 IRCT 2019-07-18 Esfahan University of Medical Sciences The effect of two drugs succinylcholine and cisatracurium in electroshock therapy. Comparison of cardiovascular changes and serum potassium levels in the use of succinylcholine and cisatracurium drugs in electroshock therapy 2018-12-06 anticipated 90 Complete https://irct.ir/trial/39750 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: .Patients were randomly assigned to two groups A and B, using Random Allocation software, and compared in two Sequence and two Period (AB, BA), Blinding description: Both drugs are prepared by the researcher using syringes of the same form and size, and the person who prescribes the drug and the person who registers the vital signs are different and are unaware of the contents of the packages. 3 Condition 1: Succinylcholine Chloride. Condition 2: cisatracurium. Intervention 1: Intervention group: After obtaining a license from the Medical Ethics Committee of Isfahan University of Medical Sciences, patients who are willing to participate in the study. In the first period with the package (b) containing 1.5 mg / kg of ketamine and 50 μg / kg of cis-atracurium and in the second period with the package (a) containing 1.5 mg / kg of ketamine and mg/kg 0.5 of succinylcholine taken under electroshock therapy. And from the right hand, blood samples are taken at the time before administration of the anesthetic drug (baseline) before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia. before induction Anesthesia is provided for patients with a simple oxygen mask and given 4 to 6 liters of oxygen for a period of three minutes. Heart monitoring includes electro-cardiogram and heart rate, pulse oximetry and non-invasive blood pressure for all patients. Heart rate, mean arterial blood pressure, diastolic blood pressure and systolic blood pressure and hemoglobin saturation from oxygen are measured at these times. Intervention 2: Control group: After obtaining a license from the Medical Ethics Committee of Isfahan University of Medical Sciences, patients who are willing to participate in the study. In the first period with the package (a) containing 1.5 mg / kg of ketamine and mg/kg 0.5 of succinylcholine and in the second period with the package (b) containing 1.5 mg / kg of ketamine and 50 μg / kg of cis-atracurium taken under electroshock therapy. And from the right hand, blood samples are taken at the time before administration of the anesthetic drug (baseline) before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia. before induction Anesthesia is provided for patients with a simple oxygen mask and given 4 to 6 liters of oxygen for a period of three minutes. Heart monitoring includes electro-cardiogram and heart rate, pulse oximetry and non-invasive blood pressure for all patients. Heart rate, mean arterial blood pressure, diastolic blood pressure and systolic blood pressure and hemoglobin saturation from oxygen are measured at these times. 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 Need to gather more information
public Atefeh Ghosouri
dehkhoda street
shahinshahr Iran (Islamic Republic of) 8316673200 +98 31 4536 2385 ghosouriatefeh@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazemalroaya
Soffeh boulevard, Shahid Keshvari highway
Isfahan Iran (Islamic Republic of) 8174675731 +98 36202020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) People under the age of 18 American Society of Anesthesiology physical status class 1,2 11 years 18 years Both Obesity (index is equal to or greater than 30 History of asthma Allergy Myocardial infarction in the last 6 months Stroke in the last 6 weeks Fibrillation and cardiac flutter Repeated ectopic treatment at the same session Having diseases like high blood pressure and hyperactivity T48.1X3 T48.1X3 Poisoning by skeletal muscle relaxants [neuromuscular blocking agents], assault Poisoning by skeletal muscle relaxants [neuromuscular blocking agents], assault Treatment - Drugs Treatment - Drugs Intervention group: After obtaining a license from the Medical Ethics Committee of Isfahan University of Medical Sciences, patients who are willing to participate in the study. In the first period with the package (b) containing 1.5 mg / kg of ketamine and 50 μg / kg of cis-atracurium and in the second period with the package (a) containing 1.5 mg / kg of ketamine and mg/kg 0.5 of succinylcholine taken under electroshock therapy. And from the right hand, blood samples are taken at the time before administration of the anesthetic drug (baseline) before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia. before induction Anesthesia is provided for patients with a simple oxygen mask and given 4 to 6 liters of oxygen for a period of three minutes. Heart monitoring includes electro-cardiogram and heart rate, pulse oximetry and non-invasive blood pressure for all patients. Heart rate, mean arterial blood pressure, diastolic blood pressure and systolic blood pressure and hemoglobin saturation from oxygen are measured at these times. Control group: After obtaining a license from the Medical Ethics Committee of Isfahan University of Medical Sciences, patients who are willing to participate in the study. In the first period with the package (a) containing 1.5 mg / kg of ketamine and mg/kg 0.5 of succinylcholine and in the second period with the package (b) containing 1.5 mg / kg of ketamine and 50 μg / kg of cis-atracurium taken under electroshock therapy. And from the right hand, blood samples are taken at the time before administration of the anesthetic drug (baseline) before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia. before induction Anesthesia is provided for patients with a simple oxygen mask and given 4 to 6 liters of oxygen for a period of three minutes. Heart monitoring includes electro-cardiogram and heart rate, pulse oximetry and non-invasive blood pressure for all patients. Heart rate, mean arterial blood pressure, diastolic blood pressure and systolic blood pressure and hemoglobin saturation from oxygen are measured at these times. Serum potassium levels. Timepoint: Before the administration of the anesthetic (baseline), before induction of the Electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia. Method of measurement: potassium test. Heart rate changes. Timepoint: Before the administration of the anesthetic (baseline), before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia. Method of measurement: Heart monitoring. Systolic blood pressure. Timepoint: Before the administration of the anesthetic (baseline), before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia. Method of measurement: Non invasive blood pressure monitor. Diastolic blood pressure. Timepoint: Before the administration of the anesthetic (baseline), before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia. Method of measurement: Non invasive blood pressure monitor. Mean arterial pressure. Timepoint: Before the administration of the anesthetic (baseline), before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia. Method of measurement: Non invasive blood pressure monitor. Oxygen saturation. Timepoint: Before the administration of the anesthetic (baseline), before induction of the electroshock (after administration of the drug), after the seizure, and 20 minutes after induction of anesthesia. Method of measurement: Percent with pulse oximeter. Recovery time. Timepoint: From the end of seizure to full consciousness. Method of measurement: In minutes using a stopwatch. Esfahan University of Medical Sciences Approved 2019-02-27 Ethics committee of Isfahan University of Medical Sciences Hezar jarib street Isfahan Isfehan Iran (Islamic Republic of)