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IRCT20160307026950N71 IRCT 2025-09-06 Esfahan University of Medical Sciences The effect of thiopental sodium and propofol in electroconvulsive therapy on seizure duration Comparative study of the effect of thiopental sodium and propofol in electroconvulsive therapy on seizure duration and threshold changes based on electroencephalogram 2025-09-22 anticipated 70 Complete https://irct.ir/trial/85621 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 70 eligible patients are randomly selected. For this, the letter A is written on 35 sheets, the letter B is written on 35 sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups, Blinding description: In order to comply with the blinding conditions before electroconvulsive therapy, two drugs, thiopental sodium 2 mg/kg and propofol 1 mg/kg, are included in packages labeled A and B. Also, 0.5 mg/kg of succinylcholine is included in both packages. Thus, package A will contain succinylcholine and thiopental, and package B will contain succinylcholine and propofol. The interventionist will inject the drug without knowing the type of drug. Also, the patient will not be aware of the type of intervention. The data collector and statistician will not be aware of the type of therapeutic intervention in either group until after the data analysis is completed. 2 Candidate for electroconvulsive therapy. Intervention 1: First intervention group: In this group, patients receive 0.5 mg/kg of succinylcholine and 2 mg/kg of sodium thiopental before electroconvulsive therapy. Intervention 2: Second intervention group: In this group, patients receive 0.5 mg/kg of succinylcholine and 1 mg/kg of propofol before electroconvulsive therapy. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr. Behzad Nazemroaya
Department of Anesthesiology, Al-Zahra Hospital, Safa Boulevard, Shahid Keshvari Highway
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Behzad Nazemroaya
Department of Anesthesiology, Al-Zahra Hospital, Safa Boulevard, Shahid Keshvari Highway
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for electroconvulsive therapy (such as patients with schizophrenia, major depression, bipolar disorder in the manic phase) Over the age of 18 Patients who have not responded adequately to medication or the individual/guardian is willing to undergo electroconvulsive therapy Patients who are at serious risk of suicide or harm to others if they do not receive electroconvulsive therapy Consent to participate in the study 18 years no limit Both Having a recent history of cardiovascular diseases such as myocardial infarction or congestive heart failure Having brain tumors, cerebral aneurysms or any increased intracranial pressure Patients with uncontrolled heart failure Patients at risk of anesthesia (ASA level 4-5) Y84.9 Medical procedure, unspecified as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Treatment - Drugs Treatment - Drugs First intervention group: In this group, patients receive 0.5 mg/kg of succinylcholine and 2 mg/kg of sodium thiopental before electroconvulsive therapy. Second intervention group: In this group, patients receive 0.5 mg/kg of succinylcholine and 1 mg/kg of propofol before electroconvulsive therapy. Seizure time. Timepoint: During the electroconvulsive therapy process. Method of measurement: Time in minutes. Seizure threshold. Timepoint: During the electroconvulsive therapy process. Method of measurement: Based on electrocardiogram (ECG). Isfahan University of Medical Sciences Approved 2025-02-12 Ethics committee of Isfahan University of Medical Sciences Vice Chancellor for Research, Building No 4, Isfahan University Of Medical Sciences, Hezarjirib Street Isfahan Isfehan Iran (Islamic Republic of)