Evaluation of the effect of quetiapine on the prevention of delirium in patients admitted to the intensive care unit (randomized clinical trial study)

Investigating the effect of quetiapine on the prevention of delirium in patients admitted to the intensive care unit (randomized clinical trial study)

This study is a randomized controlled trial with two groups. The sample size is determined through the allocation of random blocks based on the national code. The intervention group will be given quetiapine and will be monitored for three days for the occurrence of delirium and its severity. Nikham scale is used to measure the severity of delirium.

Randomization will be used to form two equal groups. The severity of delirium will be measured using Neecham's statistics. The study will compare the severity of delirium between the two groups.

Inclusion criteria: ICU hospitalization, age over 18, patient consent, no alcohol addiction, healthy vision and hearing (or corrected with glasses/hearing aids), no psychotropic drug use. Exclusion criteria: head trauma, long QT, encephalopathy, systolic blood pressure above 140, diastolic blood pressure above 90, tachycardia (beats >100/min), history of seizures, quetiapine susceptibility, intubation. Exclusion from study: patient transfer, sedative drug infusion, BP drop (>25% of baseline), death before 72 hours, QT prolongation, tachycardia (beats >100/min), neutropenia <1500.

Intervention group: Patients who are given quetiapine at a dose of 25 mg every 8 hours and trained for the occurrence of delirium. Control group: Patients who receive standard treatment for any complications and side effects, but do not receive quetiapine.

Delirium Frequency, Delirium Severity

Then the patients are divided into two groups using the permuted block randomization computer method. This method involves dividing participants into blocks and randomly assigning them to treatment groups in each block. This helps ensure balanced allocation and minimizes bias in study findings.

The triple-blind aspect of the trial refers to the fact that neither the patient, the person responsible for examining delirium, nor the statistical analyst has knowledge of which group the patient belongs to. This means that all parties involved in the study are unaware of the specific treatment or intervention being administered to each patient. This blinding process is crucial in reducing the potential for bias and ensuring the integrity of the results.The way the study is conducted is that there is an external observer in this study who assigns generic names such as A and B to the drug (intervention) and placebo (control). The participant/researcher/statistical consultant knows who is in group A and who is in group B. But no one knows whether group A is intervention or control. Finally, after the study and interpretation of the results by the statistician, the observer reveals to which group each name belonged