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IRCT20231009059668N1 IRCT 2023-10-22 Sanandaj University of Medical Sciences Effect of Propofol-Dexmedetomidine in Anesthesia Induction in Patients with Major Depression or Bipolar-Disorder under Electroconvulsive therapy Comparing the Effect of Propofol-Dexmedetomidine versus Propofol in Anesthesia Induction in Patients with Major Depression or Bipolar-Disorder under Electroconvulsive therapy 2023-10-23 anticipated 82 Complete https://irct.ir/trial/73070 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done randomly using computer generated random numbers. Thus, each "odd number" produced belongs to group 1 (intervention group) and each randomly generated "even number" belongs to group 2 (patient placement in the control group), Blinding description: To blind this study, patients do not know which study groups they are in. Also, the prepared medication (dexmedetomidine- propofol OR propofol), in the same volume and appearance, is prepared and coded by an anesthesia nurse who is not present in the study. The anesthesiologist who also performs the procedure is not aware of the prescription medication and the grouping of patients. Patients will be evaluated by an anesthesia resident who is not aware of the study groups. 3 Condition 1: Bipolar disorders. Condition 2: Major depression. Intervention 1: Intervention group: Administration of propofol at a dose of 1 mg/kg along with receiving 0.5 μg/kg of dexmedetomidine to induce anesthesia. Intervention 2: Intervention group: administration of propofol at a dose of 1 mg/kg to induce anesthesia. 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 Negin Ghadami
Pasdaran Blvd
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3362 7228 ghadaminegin@gmail.com Sanandaj University of Medical Sciences scientific Negin Ghadami
Pasdaran Blvd
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3362 7228 ghadaminegin@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Age 18 to 50 years Patient in class 1 or 2 ASA physical status Patient diagnosed with major depression or bipolar disorder referred by a psychiatrist 18 years 50 years Both History of cardiovascular, kidney, liver and lung disease History of other mental diseases, except major depression or bipolar disorder History of head trauma History of cardiovascular surgery History of allergy to propofol or foods such as eggs or soybeans Patient under treatment with bupropion and anticonvulsant The attending physician's lack of consent for the patient's participation in the study F31 F33 Bipolar disorder Major depressive disorder, recurrent Treatment - Drugs Treatment - Drugs Intervention group: Administration of propofol at a dose of 1 mg/kg along with receiving 0.5 μg/kg of dexmedetomidine to induce anesthesia. Intervention group: administration of propofol at a dose of 1 mg/kg to induce anesthesia Seizure duration. Timepoint: The end of the discharge time of the electric shock until the completion of all visible movements in all parts of the body. Method of measurement: Timer (seconds). Recovery time. Timepoint: From the end of the injection of succinylcholine to the return of breathing and opening the eyes and following the instructions completely correctly by the patients. Method of measurement: Timer (minutes). Hemodynamic changes (mean arterial pressure, heart rate). Timepoint: Before induction of anesthesia, during discharge of electric shock, 5, 10 and 15 minutes after discharge of electric shock. Method of measurement: Using a portable automatic monitoring (mean arterial pressure in mmHg and heart rate in beats per minute). Pain. Timepoint: In 5, 10 and 15 minutes after the end of the electric shock discharge and also the recovery time. Method of measurement: Visual Analogue Scale. Sedation and agitation. Timepoint: In 5, 10 and 15 minutes after the end of the electric shock discharge and also the recovery time. Method of measurement: Sedation-Agitation Scale. Sanandaj University of Medical Sciences Approved 2022-01-25 Research Ethics Committees of Kurdistan University of Medical Sciences Pasdaran Blvd Sanandaj Kurdistan Iran (Islamic Republic of)