Delirium is an acute and fluctuating disturbance in attention and awareness that frequently occurs in critically ill patients admitted to the Intensive Care Unit (ICU). It is a serious complication associated with prolonged hospitalization, increased healthcare costs, higher mortality, and long-term cognitive impairment. The stressful and disorienting ICU environment, sleep-wake cycle disruption, and use of sedative medications are key contributing factors to its development.. Delirium due to k
Conditions
Interventions
Intervention 1: Intervention group: Melatonin at a dose of 5 mg, once daily at 20:00 (8 PM) for 3 consecutive days, will be administered orally or via a nasogastric/nasoduodenal tube. The drugs are id
Sponsors
Gorgan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age between 20 and 70 years Admission to the Intensive Care Unit (ICU) Ability to receive medication orally or via a nasogastric tube within the first 48 hours of ICU admission A satisfactory level of consciousness (Glasgow Coma Scale score = 12) A satisfactory level of awareness and relative calmness (Richmond Agitation-Sedation Scale score between -2 and +2)
Exclusion criteria
Exclusion criteria: History of hypersensitivity to melatonin Refusal to provide informed consent by the patient or their legal surrogate Use of any melatonin-containing supplements or medications prior to ICU admission Discharge from the Intensive Care Unit in less than 48 hours Pregnancy or lactation Active psychosis or a pre-existing diagnosis of severe dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Delirium. Timepoint: On the morning of the fourth day of ICU admission, after completing the three-day drug administration period. Method of measurement: Confusion Assessment Method for the Intensive Care Unit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean length of stay (in days) in the Intensive Care Unit. Timepoint: At the time of patient discharge from the Intensive Care Unit. Method of measurement: Extraction from patient's electronic or paper medical records.;Mean score on the Richmond Agitation-Sedation Scale at baseline (study enrollment). Timepoint: At ICU admission (before administering the first dose of the study drug). Method of measurement: Clinical assessment and patient observation using the Richmond Agitation-Sedation Scale.;Percentage of patients experiencing any drug-related adverse effect. Timepoint: From the start of drug administration until 24 hours after the last dose. Method of measurement: Active monitoring and recording of any adverse event reported by staff or the patient.;Mean score on the Richmond Agitation-Sedation Scale at the end of the intervention period. Timepoint: On the morning of the fourth day of hospitalization, after completing the three-day drug administration period. Method of measurement: Clinical assessment and patient observation using the Richmond Agitation-Sedation Scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Ali Jabbari
Gorgan University of Medical Sciences
Outcome results
None listed