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IRCT20210622051672N1 IRCT 2021-07-22 Arak University of Medical Sciences Comparison the Effect of Remifentanil-Thiopental and Ketofol in major depression Comparison the Effect of Remifentanil-Thiopental and Ketofol on Homodynamic Responses in Patients with Major depressive disorder candidates for Electro Convulsive Therapy 2021-09-23 anticipated 80 Complete https://irct.ir/trial/57033 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients with inclusion criteria are randomly divided into two equal groups of remifentanil and thiopental (group A) and ketofol (group B) by the Anesthesia technician of the project. In this method, we have a total of 8 blocks that are formed based on the variables; The size of each block is 10 people and within each block, half of the patients from the intervention group and half from the control group are included, Blinding description: The drugs are prepared by an anesthesiologist in charge of the project and given to a fellow anesthesia resident who does not know the type of drugs. In both groups, the drug used for the intervention (remifentanil-thiopental and ketofol) is in the similar syringes and the volume of the injectable drug is increased to 5 cc for blinding. Then, the information obtained from patients will be recorded in the form of a project questionnaire by the intern in charge of the project. Finally, the information obtained from the questionnaire will be analyzed by SPSS 21 software using statistical tests and will be presented in the form of statistical tables and graphs. since this study will be conducted in double-blind method, in addition to patients, the anesthesia resident who is the assistant of the project and the intern in charge of the project will be blinded. 3 Major depressive disorder. Intervention 1: Intervention group: In group B, the anesthesia process is induced by intravenous injection of 0.5 mg / kg Ketamine with 0.5 mg / kg Propofol (Ketofol) and injection of 0.5 mg / kg Succinylcholine and 0.5 mg Atropine in group B. Intervention 2: Control group: In group A, 100 micrograms of Remifentanil is injected intravenously before induction of anesthesia. For bilateral blinding of the study, the amount of drug is increased to 5 CC with normal saline. The anesthesia process is then induced by injection of 2-3 mg / kg Sodium Thiopental , 0.5 mg / kg Succinylcholine and 0.5 mg Atropine in group A. 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 No information available
public Dr. Alireza Kamali
Valiasr Hospital, Valiasr Square, Shahid Shiroudi St.
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 alikamaliir@yahoo.com Arak University of Medical Sciences scientific Dr. Alireza Kamali
Valiasr Hospital, Valiasr Square, Shahid Shiroudi St.
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 alikamaliir@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) All patients with major depressive disorder candidates for Electro Convulsive Therapy referred to Arak Amirkabir Hospital All patients candidates for Electro-Convulsive Therapy who have signed an informed consent form to enter the study Patients in the age range of 18 to 60 years Patients with a BMI in the range of 20 to 30 Patients with major depressive disorder who do not have another psychiatric illness at the same time 18 years 60 years Both Pregnancy Breastfeeding sensitivity to Remifentanil or Thiopental or Propofol taking anticonvulsant drugs recent CVA or MI history history of underlying diseases of the heart, lungs, kidneys and liver F32.9 Major depressive disorder, single episode, unspecified Treatment - Drugs Treatment - Drugs Intervention group: In group B, the anesthesia process is induced by intravenous injection of 0.5 mg / kg Ketamine with 0.5 mg / kg Propofol (Ketofol) and injection of 0.5 mg / kg Succinylcholine and 0.5 mg Atropine in group B. Control group: In group A, 100 micrograms of Remifentanil is injected intravenously before induction of anesthesia. For bilateral blinding of the study, the amount of drug is increased to 5 CC with normal saline. The anesthesia process is then induced by injection of 2-3 mg / kg Sodium Thiopental , 0.5 mg / kg Succinylcholine and 0.5 mg Atropine in group A. Mean Arterial Pressure. Timepoint: Beginning and the end of recovery. Method of measurement: Monitor. Pulse Rate. Timepoint: Beginning and the end of recovery. Method of measurement: Monitor. Pulse oximetry (SpO2). Timepoint: Beginning and the end of recovery. Method of measurement: Monitor. Satisfaction score. Timepoint: After recovery. Method of measurement: questionnaire. Agitation Score. Timepoint: After recovery. Method of measurement: questionnaire. Duration of seizures. Timepoint: beginning and the end of seizures. Method of measurement: Minutes with chronometer. Duration of recovery. Timepoint: Beginning and the end of recovery. Method of measurement: Chronometer. Arak University of Medical Sciences Approved 2021-06-23 Ethics Committee of Arak University of Medical Sciences Research Deputy; Payambar-e-Azam Complex; Basij Square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)