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IRCT20160307026950N19 IRCT 2020-06-02 Esfahan University of Medical Sciences Esmolol and Labetalol in ECT ECT Comparison of the effectiveness of low-dose Esmolol and Labetalol on changes in heart rate and blood pressure in patients treated with electroshock (ECT) 2020-06-21 anticipated 90 Complete https://irct.ir/trial/47960 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done in a simple way and patients are distributed in intervention and control groups using Random Allocation software, Blinding description: The drugs and placebo are packaged in the same form with the same volume and coded and are randomly distributed among patients, so the participant and the clinical and evaluator are not aware of the type of drug. 3 Condition 1: Blood Pressure. Condition 2: Heart Rate. Intervention 1: Intervention Group A; Labethalol is administered at a dose of 0.2 mg per kg body weight prior to anesthesia. Intervention 2: Intervention group B; Esmolol is injected 0.5 mg per kilogram of body weight prior to anesthesia. Intervention 3: Control group C; Normal saline is injected into the patient as a placebo before injecting the anesthetic. 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 further information
public Zahra Mirelahi
No 2,Nabovvat Ave, Reza Abbasi Blvd, Ale Mohmmad St, Chamran High way
Isfahan Iran (Islamic Republic of) 8193713448 +98 31 3568 5233 zmirelahi1994@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazemoroaya
Hezarjarib Street
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) Candidate for electroshock therapy Range of 13 to 19 years ASA class I and II The patient's consent to participate in the study 13 years 19 years Both Contraindications to the use of Esmolol and Labetalol Previous consumption of beta-blockers Sensitivity to Esmolal and labetalol Asthma and drug allergies History of severe cardiovascular disease, chronic respiratory disease, kidney disease, and liver disease R03.0 R00.0 Elevated blood-pressure reading, without diagnosis of hypertension Tachycardia, unspecified Treatment - Drugs Treatment - Drugs Placebo Intervention Group A; Labethalol is administered at a dose of 0.2 mg per kg body weight prior to anesthesia. Intervention group B; Esmolol is injected 0.5 mg per kilogram of body weight prior to anesthesia. Control group C; Normal saline is injected into the patient as a placebo before injecting the anesthetic. Heart Rate. Timepoint: Before prescribing Esmolal, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock. Method of measurement: ECG monitoring and Pulse Oximeter. Systolic Blood Pressure. Timepoint: Before prescribing Esmolol, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock. Method of measurement: Non-invasive blood pressure measurement. Diastolic Blood Pressure. Timepoint: Before prescribing Esmolol, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock. Method of measurement: Non-invasive blood pressure measurement. Mean Arterial Pressure. Timepoint: Before prescribing Esmolol, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock. Method of measurement: Non-invasive blood pressure measurement. Oxygen saturation. Timepoint: Before prescribing Esmolol, labetalol, and normal saline, before prescribing anesthesia, just before the ECT, during the shock, 1, 3, 5, 10, and 20 minutes after the shock. Method of measurement: Pulse oximeter. The duration of the seizure. Timepoint: Beginning to the end of the seizure. Method of measurement: Chronometer. The duration of anesthesia. Timepoint: Beginning to the end of the anesthesia. Method of measurement: Chronometer. Recovery time. Timepoint: From the end of anesthesia to full awakening. Method of measurement: Watch. Nausea and Vomiting. Timepoint: During the stay in the recovery. Method of measurement: Ask the patient about this complication. Headache. Timepoint: During the stay in the recovery. Method of measurement: Asking from the patient. Larangospasm. Timepoint: During the stay in the recovery. Method of measurement: Monitoring. Esfahan University of Medical Sciences Approved 2020-05-01 Ethics committee of Isfahan University of Medical Sciences Hezar jarib street Isfahan Isfehan Iran (Islamic Republic of)