sleep deprivation in ICU patients
Conditions
Interventions
placebo group:oral placebo
Sponsors
Beijing Fuxing Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and more; 2. Glasgow Coma Scale(GCS-M) =10; 3. Sedation had been discontinued for a minimum of 36 hrs for propofol and alfentanil and 48 hrs for lorazep am, morphine and midazolam; 4. Estimated length of mechanical ventilation at ICU admission = 3 days; 5. patients were clinically and biologically stable, and pass the weaning screening[39], and therefore ready to be weaned from mechanical vatilation; 6. undergo the tracheotomy.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding women; 2. Preadmission treatment of sleep disturbances; 3. A history of convulsions, psychiatric or neurological disease, sleep apnoea, deafness and blindness; Alcohol consumption of greater than or equal to 50 unit per week or drug use; 4. Liver insufficiency (child-pugh C); 5. Renal insufficiency; Severe heart failure (New York Heart Association classification III/IV); 6. Intestinal obstruction, ileus, gastroparesis or other conditions likely to affect enteral absorption of melatonin; 7. Useing drugs which might alter melatonin secretion and decrease plasma levels of melatonin, such as benzo -diazepines, NSAIDs, Corticosteroids, beta-blockers, haloperidol, amiodarone; 8. known allergy to melatonin; 9. Readmitted to ICU after randomization to the study; 10. Enrolled in another trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective sleep quality; | — |
Secondary
| Measure | Time frame |
|---|---|
| subjective sleep quality;anxiety level;Delirum-free days in 28 days;Ventilation-free days in 28 days;Antibiotic -free days in 28 days;ICU/hospital length of stay; | — |
Contacts
Public ContactXi Xiuming
Beijing Fuxing Hospital, Capital Medical University
Outcome results
None listed