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IRCT20170413033408N5 IRCT 2021-02-07 Gorgan University of Medical Sciences Determining the effect of ketamine on the rate of depressive, anxiety and PTSD disorders after discharge from ICU Comparison of the effect of ketamine and midazolam with morphine on the rate of depressive and anxiety disorders and PTSD in mechanically ventilated patients in the intensive care unit 2021-02-19 anticipated 94 Complete https://irct.ir/trial/53775 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be assigned to the groups receiving ketamine and midazolam in a four-block.Therefore, we will have 6 blocks in which the order of allocating samples in groups is (AABB-ABAB-ABBA-BAAB-BABA-BBAA) and each of the blocks is assigned numbers from 1 to 6 and randomly from 1 to 6 Select a number and select the block corresponding to the desired number and assign the patients to the two groups according to the block, Blinding description: Assignment of samples to groups is done by a specialist physician so that it is not possible for the physician to blind. Patients are unaware that they are assigned to the ketamine and midazolam groups. In addition, the psychiatrist will be unaware of how patients are assigned to the groups during data collection during the study. 3 Condition 1: depressive and anxiety disorders. Condition 2: Post traumatic stress disorder. Intervention 1: Intervention group: The ketamine group is infused at a dose of 0.5 mg / kg for 15 minutes, followed by an intravenous infusion of 0.5 µ/kg/h. Intervention 2: Control group: Midazolam at 3-5mg / h and morphine at 2-3mg / h. Yes - There is a plan to make this available What will be shared: Information on the main outcome When: Since 2021 To whom: Researchers working in academic institutions Conditions: No manipulation, mentioning the data reference Where to obtain: Seyed Babak Mojaver Aghili, drbabaka35@gmail.com, Golestan University of Medical Sciences, Deputy of Research and Technology, Gorgan, Golestan, Iran, Gorgan, 4 km, Sari, How to obtain: sending an email, complete the personal and professional characteristics with documentation Comments:
public dr Babak Mojaver Aghilli
Golestan University of Medical Sciences.School of Medicine, Department of Anesthesiology, Gorgan, Shastkola road
Gorgan Iran (Islamic Republic of) 4917763681 +98 17 3115 3566 drbabaka35@gmail.com Gorgan University of Medical Sciences scientific Seyed babak Mojaveraghili
Medical school, anesthesia group, Gorgan - Sari 4th kilometers
Gorgan Iran (Islamic Republic of) 491776381 +98 17 3115 2566 dr.mojaveraghili@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) All patients should be mechanically ventilated in the ICU for at least 48 hours. Measurement Acute Physiology and Chronic Health Evaluation II Upon entering the ICU Age range 18-60 years 18 years 60 years Both Patients due to drug poisoning Patients due to suicide Patients after cardiopulmonary resuscitation Post CPR Patients with a history of brain dementia and Alzheimer's Patients with extensive cerebral hemorrhage Patients with GCS = 3 at the time of admission to the ICU Patients with a history of taking neurological drugs F41.2 F43.1 Mixed anxiety and depressive disorder Post-traumatic stress disorder (PTSD) Treatment - Drugs Treatment - Drugs Intervention group: The ketamine group is infused at a dose of 0.5 mg / kg for 15 minutes, followed by an intravenous infusion of 0.5 µ/kg/h. Control group: Midazolam at 3-5mg / h and morphine at 2-3mg / h. The rate of depressive disorders. Timepoint: Mean score of depressive disorders during two weeks, two months and six months after discharge. Method of measurement: The first interview was conducted two weeks later and the next interview was conducted two months later and six months later by telephone using Beck Depression questionnaire. Anxiety Disorders. Timepoint: Mean score of anxiety disorders during two weeks, two months and six months after discharge. Method of measurement: The first interview was conducted two weeks later and the next interview was conducted two months later and six months later by telephone using the Beck Anxiety questionnaire. PTSD Disorders. Timepoint: Mean score of PTSD disorders during two weeks, two months and six months after discharge. Method of measurement: The first interview was conducted two weeks later and the next interview two months later and six months later by telephone using the PCI questionnaire. Gorgan University of Medical Sciences Approved 2020-11-15 Ethics Committee of Golestan University of Medical Sciences Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology of Gorgan, Golestan, Iran Gorgan Golestan Iran (Islamic Republic of)