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IRCT20200927048852N1 IRCT 2020-10-13 Arak University of Medical Sciences Comparison of olanzapine and haloperidol and quetiapine on delirium Comparison of the effect of Olanzapine and Haloperidol and quetiapine on the Treatment of delirium in Intensive care unit (ICU) patients 2020-10-22 anticipated 90 Complete https://irct.ir/trial/51260 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Three-group web randomization (www.graphpad.com) was used to create a simple random sequence and to conceal random allocation, the SNOSE closed envelope method Will be used. a number of envelopes will be prepared and each of the random sequences created will be registered on a card and the cards will be placed inside the envelopes in order. In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface. Finally, the letter envelopes are glued and placed inside the boxes, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants to study, one of the envelopes is opened in order and the assigned group of the participant is revealed, Blinding description: The study is a double-blind clinical trial and the implementers of the project with the help of treatment staff will try to conduct the study without any bias according to the principles of the project. In this regard, only the main researcher is aware of the study groups and patients. He is not aware and as much as possible he tries to prepare drugs with the same shape, color and size and prescribe them according to the same principles and using a nasogastric tube. Also, the clinical caregiver and outcome assessor are not aware of the type of groups and identify patients based on groups A, B and C. 3 Delirium. Intervention 1: First intervention group: In the first group, patients with delirium receive haloperidol (Sobhan Daru Company - Iran) at a dose of 2.5 mg per day, once daily and orally for 10 days until the end of the intervention. Intervention 2: Second intervention group: In the second group, patients with delirium receive olanzapine (Sobhan Daru Company - Iran) at a dose of 2.5 to 10 mg per day daily and orally until the end of the intervention for 10 days. Intervention 3: Third intervention group: In the third group, patients with delirium receive quetiapine (Bakhtar Shimi-Iran Pharmaceutical Company) at a dose of 12.5 to 75 mg daily and orally for 10 days until the end of the intervention. 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 more information
public Mohamad Eslami
School of Medicine, Payambar-e-azam Complex, Sardasht Town
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3520 daneshkadeha@arakmu.ac.ir Arak University of Medical Sciences scientific Mohamad Eslami
School of Medicine, Payambar-e-azam Complex, Sardasht Tow
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3520 daneshkadeha@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All patients who have been diagnosed with delirium by the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and have suffered a brain injury 18 years no limit Both primary neurological diseases such as stroke, dementia, psychosis pregnancy and lactation modified QT interval more than 440 milliseconds F05 Delirium due to known physiological condition Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group: In the first group, patients with delirium receive haloperidol (Sobhan Daru Company - Iran) at a dose of 2.5 mg per day, once daily and orally for 10 days until the end of the intervention. Second intervention group: In the second group, patients with delirium receive olanzapine (Sobhan Daru Company - Iran) at a dose of 2.5 to 10 mg per day daily and orally until the end of the intervention for 10 days. Third intervention group: In the third group, patients with delirium receive quetiapine (Bakhtar Shimi-Iran Pharmaceutical Company) at a dose of 12.5 to 75 mg daily and orally for 10 days until the end of the intervention. Sedation. Timepoint: Before the intervention and the third, seventh and tenth days after the intervention. Method of measurement: Richmond Agitation and Sedation Scale. Illness severity. Timepoint: Before the intervention and the third, seventh and tenth days after the start of the intervention. Method of measurement: Acute Physiology and Chronic Health Evaluation II. Arak University of Medical Sciences Approved 2020-05-12 Ethics committee of Arak University of Medical Sciences Payambar-e-azam Complex, Basij Sq., Sardash Townt Arak Markazi Iran (Islamic Republic of)