The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients : Randomized, Placebo-controlled, Double Blind Study

Conditions
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Delirium

Intervention / Treatment
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* Dietary Supplement: Melatonin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: melatonin group<br>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 Supplement: Melatonin<br>* 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.<br>|
| Placebo Comparator: control group<br>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. | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly ICU patients