Comparison of the effect of Olanzapine and Haloperidol and quetiapine on the Treatment of delirium in Intensive care unit (ICU) patients

The effect of olanzapine, haloperidol and quetiapine in the treatment of delirium in Intensive care unit (ICU) patients in Valiasr Hospital in Arak is compared.

A Phase 3 parallel randomized double-blind clinical trial without a control group on 90 patients using three-group web randomization (www.graphpad.com)

This study will be performed in Valiasr Hospital and Amir Al-Momenin Hospital in Arak. In this way, 90 patients with delirium admitted to the intensive care unit will be randomly divided into three groups: haloperidol, olanzapine and quetiapine . In this study,drugs in the same shape, size and color will be prepared, so patients are not aware of the type of drug used and only the main performer is aware of the study groups and Clinical caregiver and intervention outcome assessor are not aware of the study groups and recognize them only on the basis of letters A, B and C.Patients will be treated for 10 days and the severity of the disease and the degree of relief of patients will be evaluated before the intervention and 3, 7 and 10 days after.

Inclusion criteria: Patients who have been diagnosed with delirium by DSM V criteria and are over 18 years of age and have a brain injury. Exclusion criteria : Stroke, dementia, psychosis, pregnancy and lactation, QT interval more than 440 milliseconds

Intervention group 1: haloperidol (Sobhan Daru Company - Iran) at a dose of 2.5 mg per day for up to 10 days Intervention group 2: olanzapine (Sobhan Daru Company - Iran) at a dose of 2.5-10 mg per day for up to 10 days Intervention group 3: quetiapine (Bakhtar Shimi-Iran Pharmaceutical Company) at a dose of 12.5 to 75 mg per day for up to 10 days

sedation, severity of illness

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.

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.