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Terminate the study because it is difficult to recruit the subject.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| melatonin group | Experimental | 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. |
|
| control group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Dietary Supplement | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of delirium | The score of ICD-SC(Intensive Care Delirium Screening Checklist) will be recorded to identify the incidence of delirium for 5 days after surgery. | 5 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| change of amount of used vasopressors as a measure of intraoperative hemodynamics | intra-procedural hemodynamics measured by amount of used vasopressors | up to 5 days |
| total amount of sedatives |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Dietary Supplement | 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. |
|
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |