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IRCT2016081229310N1 IRCT 2016-09-21 Vice chancellor for research Isfahan University of Medical Sciences Comparison of effect of Succinylcholine and Cisatracurium on seizure time in electroconvulsive therapy Comparison of effect of Succinylcholine and Cisatracurium in seizure time in electroconvulsive therapy in children with psychologic disease 2016-08-31 anticipated 60 Complete https://irct.ir/trial/23593 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Other design features: Randomization will be done with table of randomized numbers. 3 Condition 1: Attention deficit-hyperactivity disorder(ADHD). Condition 2: anorexia nervosa. Condition 3: mental retard. Condition 4: schizophrenia. Condition 5: depression. Condition 6: bipolar disorder. Condition 7: psychosis. Condition 8: conduct disorder. Condition 9: Obsessive-compulsive disorder(OCD). Condition 10: anxiety disorder. Intervention 1: Group B (the control group): After taking informed consent from patients, an appropriate intravenous (IV) line will be taken and ECG and pulse oximeter and noninvasive blood pressure devices will be attached to the patients. Pharmaceutical package B which consists of 0.5 mg/kg of Succinylcholine and 2mg/kg of Sodium thiopantal will be injected through IV line.Then ECT will be attached bi-temporally and shocks will be applied to the patient and then time of tonic and clonic phases and also time of seizure will be measured by chronometer. Intervention 2: Group A (intervention group): After taking informed consent from patients, an appropriate intravenous (IV) line will be taken and ECG and pulse oximeter and noninvasive blood pressure devices will be attached to the patients. Pharmaceutical package A which consists of 50µg/kg of Cisatracurium and 2mg/kg of Sodium thiopantal will be injected through IV line. Then ECT will be attached bi-temporally to the patient and shocks will be applied to the patient. Then time of tonic and colonic phases and also duration of seizure will be measured by chronometer.
public Forough Mirzakhani Hafshejani
Isfahan University of Medical Sciences, Hezar jarib street, Azadi square, Isfahan
Isfahan Iran (Islamic Republic of) 814673461 +98 31 3668 0048 frmirzakhani@gmail.com Isfahan university of medical sciences scientific Behzad Nazemroaya
International Bureau, Isfahan University of Medical Sciences, P.O. Box 319, Hezar-Jerib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 36680048 b.nazemroaya@khuisf.ac.ir Isfahan University Of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: patients under 25 years who are candidates for electroconvulsive therapy (ECT). Exclusion criteria: persistent medical problems, seizure more than 90 seconds and less than 20 seconds, need to intubation, severe allergy, past history of seizure and epilepsy, addiction to alchohol and drugs. no limit 25 years Both F90 F50 F70,F71,F7 F20 F32 F30 F23 F91 F42 F41 Disturbance of activity and attention Anorexia nervosa Mental retardation schizophrenia Depressive episode manic episode acute and transient psychotic disorders conduct disorder obsessive compulsive disorder Other anxiety disorders Treatment - Drugs Treatment - Drugs Group B (the control group): After taking informed consent from patients, an appropriate intravenous (IV) line will be taken and ECG and pulse oximeter and noninvasive blood pressure devices will be attached to the patients. Pharmaceutical package B which consists of 0.5 mg/kg of Succinylcholine and 2mg/kg of Sodium thiopantal will be injected through IV line.Then ECT will be attached bi-temporally and shocks will be applied to the patient and then time of tonic and clonic phases and also time of seizure will be measured by chronometer. Group A (intervention group): After taking informed consent from patients, an appropriate intravenous (IV) line will be taken and ECG and pulse oximeter and noninvasive blood pressure devices will be attached to the patients. Pharmaceutical package A which consists of 50µg/kg of Cisatracurium and 2mg/kg of Sodium thiopantal will be injected through IV line. Then ECT will be attached bi-temporally to the patient and shocks will be applied to the patient. Then time of tonic and colonic phases and also duration of seizure will be measured by chronometer Duration of seizure. Timepoint: after intervention. Method of measurement: in seconds using a chronometer. Duration of tonic phase. Timepoint: after intervention. Method of measurement: in seconds using a chronometer. Duration of clonic phase. Timepoint: after intervention. Method of measurement: in seconds using a chronometer. Blood Pressure. Timepoint: 1, 5 and 10 seconds after the shock. Method of measurement: mmhg with Manometer. Pulse. Timepoint: 1, 5 and 10 seconds after the shock. Method of measurement: Beat per minute with Pulse Oximeter. Beat per minute with Pulse Oximeter. Timepoint: O2 saturation. Method of measurement: Percent with Pulse Oximeter. Recovery Duration. Timepoint: From the end of seizure to full consciousness. Method of measurement: Minute with Timer. Back to Breathe Spontaneously. Timepoint: From the end of seizure to respiration. Method of measurement: Second with Timer. Cough. Timepoint: After recovery. Method of measurement: Ask the patient. Nausea and Vomiting. Timepoint: After recovery. Method of measurement: Ask the patient. Headache. Timepoint: After recovery. Method of measurement: Ask the patient. Muscle Pain. Timepoint: After recovery. Method of measurement: Ask the patient. Laryngospasm. Timepoint: After recovery. Method of measurement: Evaluation of patient such as breathing and o2 sat. Vice chancellor for research Isfahan University of Medical Sciences Approved 2016-06-20 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar jarib street, Azadi square, Isfahan Isfahan Iran (Islamic Republic of)