Comparison of the effect of two prophylactic doses of tablet melatonin on incidence of delirium in patients admitted in intensive care unit
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of delirium
研究概览
简要总结
This study is a prospective, interventional study to compare the effect of two doses of tablet melatonin on occurrence of ICU delirium , with the hypothesis that 6mg dose of melatonin causes a significantly greater reduction in the incidence of delirium as compared to the 3mg dose in patients admitted in Intensive Care Unit. Oral Melatonin 6mg and 3mg will be administered within 48 hours of ICU admission in each groups and GCS, RASS and CAM ICU Scores will be performed by an ICU Doctor initially ,Baseline- on the day of admission and later twice a day, once at the start of the day at 09:00 AM and after giving melatonin at 09:00 PM for five days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Preserved oral/enteral intake within the first 48 hours of ICU admission.
- •Patients requiring an ICU stay of at least 5 days.
- •Richmond Agitation Sedation Scale (RASS) score within + 2 or.
- •2 on admission.
排除标准
- •Hemodynamically unstable patients or on vasopressor support
- •Patients on psychotropic medications or having known psychiatric illness
- •Patients with debilitating neurological diseases and low GCS less than 10 on admission
- •Pregnant patients
- •Patient with known or suspected allergy to melatonin.
结局指标
主要结局
Incidence of delirium
时间窗: Twice a day once at 9 am and after giving the melatonin tablet at 9pm for a period of 5 days
次要结局
- 1. To compare length of Intensive Care Unit stay in 2 study groups.(2. To compare the incidence of headache, dizziness and day-time sleepiness between the)
研究者
Dr Ajith Kumar P
Vardhman Mahavir Medical College and Safdarjung Hospital