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IRCT20220508054780N4 IRCT 2024-01-21 Mashhad University of Medical Sciences The effectiveness of agomelatine on rate of delirium A clinical trial to compare the effectiveness of agomelatine with placebo on rate of delirium in patients admitted to the cardiac surgery intensive care unit 2024-02-20 anticipated 74 Complete https://irct.ir/trial/75032 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be simple randomly assigned to two groups using a random table type and opaque envelopes will be used for concealment, Blinding description: Patients admitted to the cardiac surgery intensive care unit to Imam Reza Hospital, Mashhad, Iran are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive the agomelatine and control will receive placebo. The participants and person responsible for data collection are blind to group allocation and the type of treatment. 1-2 Delirium. Intervention 1: Intervention group: The intervention group will receive 25 mg agomelatine (Tadbir Kalaye Jam, Tehran, Iran) orally 18 hours after hospitalization. This will be administered daily for a minimum of 3 days and a maximum of 14 days, in addition to their prescribed medications. Intervention 2: Control group: The control group will receive placebo (It has the same color, taste, structure and shape as agomelatine, produced by the research center of faculty of pharmacy, Mashhad University of Medical Sciences) orally 18 hours after hospitalization. This will be administered daily for a minimum of 3 days and a maximum of 14 days, in addition to their prescribed medications. Yes - There is a plan to make this available What will be shared: The research data obtained from the main outcomes of the study can be shared freely as 'open data'. When: 6 months after publishing the results To whom: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Conditions: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Where to obtain: Benyamin Fazli provides the data analysis to the applicants via email: fazlib@mums.ac.ir How to obtain: Applicants can send emails to him and receive a response within a week. Comments:
public Benyamin Fazli
Anesthesiology department. Mashhad University of medical sciences , University ave .,Mashhad, Razavi Khorasan Province, Iran
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2711 fazlib@mums.ac.ir Mashhad University of Medical Sciences scientific Alireza Sedaghat
Imam Reza Hospital, Imam Reza Square
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2711 sedaghatar@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Aged between 18 and 75 years Staying more than 72 hours in the intensive care unit Receiving medication following admission to hospital from the first day Having stable hemodynamics based on confusion assessment method for the ICU (CAM-ICU) 18 years 75 years Both Patients who were treated with agomelatine before ICU admission Having agomelatine allergies Pregnant and breastfeeding women Having Alzheimer Having hepatic dysfunction Having high APACHE II score The patient dies in the first 3 days of admission Patients who require of only parenteral nutrition Using strong 1A2 inhibitors (ciprofloxacin, fluvoxamine) F05 Delirium not superimposed on dementia, so described Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will receive 25 mg agomelatine (Tadbir Kalaye Jam, Tehran, Iran) orally 18 hours after hospitalization. This will be administered daily for a minimum of 3 days and a maximum of 14 days, in addition to their prescribed medications. Control group: The control group will receive placebo (It has the same color, taste, structure and shape as agomelatine, produced by the research center of faculty of pharmacy, Mashhad University of Medical Sciences) orally 18 hours after hospitalization. This will be administered daily for a minimum of 3 days and a maximum of 14 days, in addition to their prescribed medications. Incidence and severity of delirium. Timepoint: Before the intervention and twice a day until the end of the intervention. Method of measurement: Based on Confusion Assessment Method for the ICU (CAM-ICU). Sleep quality. Timepoint: Before the intervention and twice a day until the end of the intervention. Method of measurement: Based on Pittsburgh Sleep Quality Index (PSQI). Pain management. Timepoint: Before the intervention and twice a day until the end of the intervention. Method of measurement: Based on Critical-care pain observation tool (CPOT). Duration of hospital care unit stays. Timepoint: After intervention. Method of measurement: Based on the number of days of hospitalization. Number of days dependent on ventilator. Timepoint: After intervention. Method of measurement: The number of days the ventilator is used for the patient. Mortality rate. Timepoint: After intervention. Method of measurement: Based on acute physiology and chronic health evaluation score (APACHE) II score. Mashhad University of Medical Sciences Approved 2023-07-24 Imam Reza Hospital Educational, Research and Treatment Center, Ethics Committee of Mashhad Universit Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)