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IRCT20211009052708N1 IRCT 2021-10-28 Semnan University of Medical Sciences Comparison of the effect of ketamine-propofol combination with ketamine-thiopental in improving depressive symptoms in patients undergoing electroconvulsive therapy The Comparison of the effect of combining Ketamine-Propofol and Ketamine- Thiopental during Electroconvulsive Therapy in Reducing the Symptoms in Patients with Major Depression Disorder :a clinical trial 2021-10-23 anticipated 60 Complete https://irct.ir/trial/59219 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization (quadruple blocks) All possible blocks are arranged as follows: block 1: ABAB block 2: AABB block 3: ABBA block 4: BBAA block 5: BABA block 6: BAAB We need 15 blocks to select 60 people. We randomly select these blocks from the numbers 1 to 6.Using R software, we choose a random number between the numbers 1 to 6. For example, number 6 is chosen as the first block and number 2 as the forth block. The people who enter the study are given B-A-A-BA- A-B-B, respectively.Finally, group 1 and group 2 will be identified. 3 Depression. Intervention 1: Intervention group: Combination of thiopental at a dose of 3 mg / kg with ketamine at a dose of 0.5 mg / kg after administration of 0.5 mg atropine at the beginning of ECT. Intervention 2: Control group: Combination of 1.5 mg /kg propofol with 0.5 mg/kg of ketamine patient after 0.5 mg atropine at the beginning of ECT. 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 more information
public Aysan Taravati
Semnan University of Medical Sciences
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3344 1022 dr.a.taravati@gmail.com Semnan University of Medical Sciences scientific Aysan Taravati
Semnan University of Medical Sciences
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3344 1022 dr.a.taravati@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Includes: Diagnosis of moderate to severe depression episode affected by DSM-5 age at least 18 years performance and willingness to provide written consent by patient or legal guardian verbal IQ of 8.5 or greater undergoing ECT treatment in the past six months To be caught 18 years 60 years Both Inability to provide informed written consent in the absence of a legal guardian primary psychotic or schizoaffective disorder obsessive-compulsive disorder concomitant diagnosis of multiple psychiatric disorders in axis one and two anorexia nervosa history of substance or alcohol dependence sensitivity to Anesthesia drugs or contraindications for their administration ECT in the last three months contraindications for ECT such as organic brain diseases and dementia major medical conditions that affect neuropsychological function pregnancy or lack of proper contraception breastfeeding Occurrence of psychotic symptoms or exacerbation of depressive symptoms during the study F06.32 Mood disorder due to known physiological condition with major depressive-like episode Treatment - Drugs Treatment - Drugs Intervention group: Combination of thiopental at a dose of 3 mg / kg with ketamine at a dose of 0.5 mg / kg after administration of 0.5 mg atropine at the beginning of ECT Control group: Combination of 1.5 mg /kg propofol with 0.5 mg/kg of ketamine patient after 0.5 mg atropine at the beginning of ECT Depression score in Beck questionnaire. Timepoint: Before the start of the first ECT session and at the end of the third and sixth sessions, the Beck Depression Inventory test is performed on all samples. Method of measurement: Beck Depression Inventory. Quality of life score. Timepoint: After the end of the treatment period. Method of measurement: Short questionnaire SF-12. Semnan University of Medical Sciences Approved 2021-10-04 Semnan University of Medical Sciences - Research and development Vice Semnan University of Medical Sciences Semnan Semnan Iran (Islamic Republic of)