Health Condition 1: G969- Disorder of central nervous system, unspecified
Conditions
Interventions
Intervention1: tablet melatonin: 3 mg once a day enterally at 9 PM for 7 consecutive days
Control Intervention1: Placebo inert compound: administered enterally once a day for 7 consecutive days for 7
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: All patients with an expected ICU stay of more than 24 hours will be assessed for inclusion
Exclusion criteria
Exclusion criteria: 1. pregnant/breastfeeding females 2. comatose patients 3. patients who are delirious on ICU admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether prophylactic melatonin decreases the incidence of delirium in the first 24 hours of ICU admission in critically ill patients as compared to placebo.Timepoint: To determine whether prophylactic melatonin decreases the incidence of delirium in the first 24 hours of ICU admission in critically ill patients as compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether prophylactic melatonin decreases the incidence of delirium in the first 7 days of ICU admission in critically ill patients as compared to placeboTimepoint: first 7 days;To determine whether prophylactic melatonin is associated with better Glasgow Outcome scores at discharge from ICUTimepoint: at discharge from ICU;To determine whether prophylactic melatonin is associated with decrease in- a. Length of ICU stay b. Duration of mechanical ventilation c. ICU mortality as compared to placebo. Timepoint: at discharge from ICU | — |
Countries
India
Contacts
Public ContactDr LN Yaddanapudi
PGIMER, chandigarh
Outcome results
None listed