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IRCT20180520039739N5 IRCT 2023-06-20 Esfahan University of Medical Sciences Effect of Quetiapine in Preventing Delirium in ICU Patients Evaluation of the effect of quetiapine on the prevention of delirium in patients admitted to the intensive care unit (randomized clinical trial study) 2023-05-24 anticipated 98 Complete https://irct.ir/trial/69279 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 patient admitted to the intensive care unit. Intervention 1: Intervention group: The intervention in this study involves administering quetiapine, a medication commonly used to treat psychiatric disorders. The dose of quetiapine given is 25 mg, which is administered every 8 hours for three days. The patients are trained by a nurse or a doctor to report any occurrence of delirium at regular intervals (every 8 hours) for three days, and the occurrence of delirium, its intensity, and duration are recorded by the relevant nurse using the Neecham Anesthesia scale. If any complications arise due to the use of the medication, it is immediately discontinued, and standard treatment is provided to manage the side effects. These side effects include a drop in blood pressure by more than 25% of baseline pressure, tachycardia (heartbeats more than 100 per minute), and neutropenia (reduction in white blood cell count) less than 1500. Intervention 2: Control group: the control group is the group of patients who did not receive the intervention (quetiapine). They are used as a comparison group to evaluate the effectiveness of the intervention group (the group that received quetiapine). The control group is randomly selected and receives the same care and attention as the intervention group except for the administration of the drug. 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 Mohammadreza Habibzadeh siahroodkolaee
ALZAHRA hospital
Isfahan Iran (Islamic Republic of) ندارد +98 31 3532 0551 gsmhabibzadeh@yahoo.com Esfahan University of Medical Sciences scientific Mohammadreza Habibzadeh siahroodkolaee
ALZAHRA hospital
Isfahan Iran (Islamic Republic of) ندارد +98 31 3532 0551 gsmhabibzadeh@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Hospitalization in the intensive care unit Age over 18 years Patient satisfaction No alcohol addiction Healthy vision and hearing or elimination of vision and hearing defects by using glasses and hearing aids No use of psychoactive drugs 18 years no limit Both head trauma QT prolongation Encephalopathy Basal systolic blood pressure above 140 Basal diastolic blood pressure above 90 Tachycardia (beats more than 100 per minute) History of seizures Hypersensitivity to quetiapine intubated patient F05 Delirium due to known physiological condition Treatment - Drugs Treatment - Drugs Intervention group: The intervention in this study involves administering quetiapine, a medication commonly used to treat psychiatric disorders. The dose of quetiapine given is 25 mg, which is administered every 8 hours for three days. The patients are trained by a nurse or a doctor to report any occurrence of delirium at regular intervals (every 8 hours) for three days, and the occurrence of delirium, its intensity, and duration are recorded by the relevant nurse using the Neecham Anesthesia scale. If any complications arise due to the use of the medication, it is immediately discontinued, and standard treatment is provided to manage the side effects. These side effects include a drop in blood pressure by more than 25% of baseline pressure, tachycardia (heartbeats more than 100 per minute), and neutropenia (reduction in white blood cell count) less than 1500. Control group: the control group is the group of patients who did not receive the intervention (quetiapine). They are used as a comparison group to evaluate the effectiveness of the intervention group (the group that received quetiapine). The control group is randomly selected and receives the same care and attention as the intervention group except for the administration of the drug. Delirium Frequency. Timepoint: every 8 hours. Method of measurement: The number of episodes of delirium observed in an 8-hour period. This variable measures how often delusions occur in each group And it is measured using the Neecham criterion. Severity of delirium. Timepoint: every 8 hours. Method of measurement: The intensity or severity of delirium symptoms experienced by participants was measured using the Neecham scale. Esfahan University of Medical Sciences Approved 2022-02-04 Ethical Committee in Biomedical Researches, Faculty of Medicine, Isfahan University of Medical Scien Faculty of medicine, Isfahan university of medical science, Hezar Jerib Avenue, Isfahan, Iran. Isfahan Isfehan Iran (Islamic Republic of)