Evaluation of role of exogenous melatonin in prevention of delirium in postoperative patients admitted in the intensive care unit
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The patients will be categorized as “Delirious†or “Not Delirious†on the basis of the results from the CAM-ICU scale and results will be analyzed.
研究概览
简要总结
The relationship betweenthe ICU environment and the development of delirium shows an altered release ofmelatonin and a fragmentation of biological and circadian rhythms. Duringcritical illness, there is abnormal release of melatonin and its plasmaconcentration and that of its urinary metabolite are altered
The interest in melatonin as apotential therapeutic or prophylactic agent in the management of sleepdisturbances and potentially delirium in the ICU derives from demonstrated lowplasma concentrations and altered secretion patterns of melatonin in the criticallyill (which was mainly established by measurements of the principle metaboliteof 6-sulphatoxymelatonin (MT6) in the urine of subjects)
Hence this study will evaluatethe role of exogenous melatonin in prevention of delirium in postoperativepatients admitted in intensive care unit and measurement of outcome byoccurrence of delirium as determined by confusion assessment – method (CAM)criteria and will attempt toestablish the reduction in incidence of delirium in post operativepatients admitted in ICU after administration of exogenous oral melatonin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Postoperative patients who are going to be ventilated more than 48 hours in the trauma ventilatory unit.
- •Adults (20years.
- •60 years) able to receive medication enterally (oral or via nasogastric tube) during first 48 hours of admission.
排除标准
- •â€“Not giving consent –Sensitivity or history of allergic reaction to melatonin supplement, –Pregnant –Patients with paralytic ileus.
- •â€“Patient having expected stay or life expectancy of less than 48 hours –Preexisting Premorbid pathologies particularly cognitive dysfunction, dementia, psychiatric disorders or sleep disorders –Patients with history of head injury , substance abuse or withdrawal.
- •â€“Patients with Hearing impairments.
结局指标
主要结局
The patients will be categorized as “Delirious†or “Not Delirious†on the basis of the results from the CAM-ICU scale and results will be analyzed.
时间窗: from admission into ICU to discharge from ICU
On the day of discharge/transfer patient will be assessed using the CAM-ICU (Confusion Assessment Method) scale.
时间窗: from admission into ICU to discharge from ICU
次要结局
- NA(NA)