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IRCT20141209020258N129 IRCT 2020-01-12 Arak University of Medical Sciences Effect of combination of Propofol-Remifentanil vs Ketofel in duration of seizure and hemodynamic signs of psychotics patient in electroconvulsive therapy Effect of combination of Propofol-Remifentanil versus Ketofel in duration of seizure and hemodynamic signs of psychotics patient in electroconvulsive therapy 2019-05-05 anticipated 105 Complete https://irct.ir/trial/43098 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with randomization with envelopes in 3 groups A and B and C.‏ In this method, we selected a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size, Blinding description: This study is double blind. Researcher who complete questionnaire and analyzer and participant are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B and C are available to analyzer and outcome assessor. 2-3 psychotics patient. Intervention 1: Intervention group1: We will inject Remifentanil 1 milligram in kilogram (Produced by Normon Company) and Propofol 1 milligram in kilogram. Intervention 2: Intervention group2: We will inject Ketamin 1 milligram in kilogram (Ferdows & Razi company) and Propofol 1 milligram in kilogram. Intervention 3: Control group: We will inject distilled water and propofol 1 milligram in kilogram. Yes - There is a plan to make this available What will be shared: When we publish article in journal When: After the article is published To whom: researcher in university Conditions: If there are additional questions Where to obtain: Dr Bijan Yazdi How to obtain: They have to write letters to the professors and the university Comments:
public Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific dr Bijan Yazdi
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 yazdi@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) 18 to 50 years Patients with a diagnosis of major schizophrenia depression of catatonia or bipolar disorder ASA class I and II 18 years 50 years Both Sensitivity to medications used Drug history History of cardiovascular disease Pregnancy Patients in need of treatment for hemodynamic instability following seizures, who had less than 25 second tonic or clonic seizures, or had more than 60% energy to induce seizures F06.0 Psychotic disorder with hallucinations due to known physiological condition Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1: We will inject Remifentanil 1 milligram in kilogram (Produced by Normon Company) and Propofol 1 milligram in kilogram. Intervention group2: We will inject Ketamin 1 milligram in kilogram (Ferdows & Razi company) and Propofol 1 milligram in kilogram. Control group: We will inject distilled water and propofol 1 milligram in kilogram. Mean arterial pressure. Timepoint: At baseline, 1, 2, and 3 minutes after shock and after recovery. Method of measurement: Barometer. Heart rate. Timepoint: At baseline, 1, 2, and 3 minutes after shock and after recovery. Method of measurement: Count. Oxygen saturation percentage. Timepoint: At baseline, 1, 2, and 3 minutes after shock and after recovery. Method of measurement: Pulse oximetry. Duration of seizures. Timepoint: After electro convulsive therapy. Method of measurement: Minute. Arak University of Medical Sciences Approved 2019-04-15 Ethics Committe Arak University Of Medical Sciences Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)