Delirium
Conditions
Keywords
elderly ICU patients
Brief summary
Delirium in older patients is associated with increased mortality and health care costs. And delirium is frequent in intensive care unit (ICU). Circadian rhythm alteration is one of the most important risk factor for developing delirium. In this study, investigators will investigate the effect of administration of melatonin on postoperative delirium in elderly ICU patients. Randomly selected patients of the melatonin group are given 5mg of melatonin in the evening from the day before surgery to the the 5th postoperation day. In contrast, patients in the control group are given placebo. Primary outcome of this study is the incidence of postoperative delirium measured by ICD-SC (Intensive Care delirium Screening Checklist). And secondary outcome includes intra-procedural hemodynamics measured by amount of used vasopressors, heart rate and blood pressure, total amount of sedatives, total amount of analgesics, duration of mechanical ventilation, duration of ICU stay. Thus, investigators perform this study to investigate the relationship between delirium and circadian rhythm.
Interventions
DIETARY_SUPPLEMENTMelatonin
Patients in the melatonin group are given 5mg of melatonin at 8 pm the day before surgery, POD#0, POD#1, POD#2, POD#3, POD#4, and POD#5.
DIETARY_SUPPLEMENTPlacebo
Patients in the control group are given placebo at 8 pm the day before surgery, POD#0, POD#1, POD#2, POD#3, POD#4, and POD#5.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* older than 50 years old * patients who admitted to ICU after surgery
Exclusion criteria
* Subjects are ineligible if they have cognitive dysfunction, * disabling mental change disorder, * alcohol addiction, * dementia, * cerebrovascular accident, * transient ischemic attack, * carotid artery stenosis, * autoimmune disease, * patients who are unable to communicate or speak Korean, * emergent operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of delirium | 5 days after surgery | The score of ICD-SC(Intensive Care Delirium Screening Checklist) will be recorded to identify the incidence of delirium for 5 days after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of amount of used vasopressors as a measure of intraoperative hemodynamics | up to 5 days | intra-procedural hemodynamics measured by amount of used vasopressors |
| total amount of sedatives | up to 5 days | — |
| total amount of analgesics | up to 5 days | — |
| duration of mechanical ventilation | up to 5 days | — |
| duration of ICU stay | up to 5 days | — |
Countries
South Korea
Outcome results
None listed