The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients : Randomized, Placebo-controlled, Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- incidence of delirium
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 50 years old
- •patients who admitted to ICU after surgery
排除标准
- •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
研究组 & 干预措施
control group
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.
干预措施: Placebo (Dietary Supplement)
melatonin group
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.
干预措施: Melatonin (Dietary Supplement)
结局指标
主要结局
incidence of delirium
时间窗: 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.
次要结局
- change of amount of used vasopressors as a measure of intraoperative hemodynamics(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)