Health Condition 1: F05- Delirium due to known physiological condition
Conditions
Interventions
Intervention1: Tablet Melatonin: oraly administered 3mg single dose daily for 5 days
Control Intervention1: Tab. Melatonin: 6mg orally daily for 5 dsys
Sponsors
Dr Priyamvada Gupta
Eligibility
Inclusion criteria
Inclusion criteria: 1.Critically ill patients Age >18 or 2. Within the first 24 h of admission in the ICU 3.Anticipated ICU stay 5 days or more 4.No basic delirium or mood changes before admission in ICU
Exclusion criteria
Exclusion criteria: If they had less than 5 days of ICU stay 2. Sensitivity reaction to the melatonin supplement. 3. Pregnancy 4. Previous history of seizure or active seizure 5. ICU admission more than 24 hours at the time of screening 6. Unable to assess for delirium 7. History of severe cognitive or neurodegenerative disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the occurrence of delirium in critically ill patients receiving two different doses of melatonin and placebo group in terms of the following parameters:- â?¢ Delirium incidence (CAMICUS score â?¥4) and subsyndromal delirium (CAMICUS score of 1â??3) â?¢ Time to onset of delirium â?¢ Severity of delirium â?¢delirium duration â?¢and delirium-free days (at ICU discharge)Timepoint: every 24 to 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To observe the length of stay in ICU 2. To observe adverse effects of melatonin 3. Self-reported sleep quality (Richards Campbell Sleep Questionnaire (RCSQ)) Timepoint: every 24 to 48 hours | — |
Countries
India
Contacts
Public ContactSonali Devgan
Mahatma Gandhi University of Medical Science and Technology
Outcome results
None listed