The effectiveness of agomelatine on rate of delirium
Phase 1
- Conditions
- Delirium.Delirium not superimposed on dementia, so described
- Registration Number
- IRCT20220508054780N4
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
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)
Exclusion Criteria
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method 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.