Efficacy of Melatonin in Prevention of Delirium in Intensive Care Unit: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
研究概览
简要总结
BACKGROUND OF PRESENT STUDY: Delirium is a common and serious syndrome pf acute brain dysfunction associated with negative outcomes.Melatonin may have a role in delirium prevention for critically ill adults based on data from non critically ill patient populations.Our objective was to the hypothesis that Melatonin given prophylactically may have a role in preventing delirium in adults who are critically ill.
OBJECTIVE OF PROPOSED RESEARCH: To assess the effectiveness of Melatonin in preventing ICU delirium in critically ill patients.
METHODOLOGY:A Prospective Observational Study Design will be employed,selecting patients who meet specified inclusion criteria.Participants will be randomly allotted to either Melatonin intervention group (Group-M) or a Control group (Group-C) receiving conventional therapy. The intervention involves giving Syrup Melatonin 3mg orally or via nasogastric tube at 9pm daily for 14 days.Outcomes assessed will include incidence and duration of Delirium.
EXPECTED OUTCOME: As this is a prospective study, the outcome will be obtained only after the recording,compilation and analysis of data.However, as per previous studies, it is anticipated that Melatonin supplementation may reduce the incidence of Delirium in ICU patients by promoting sleep and stabilizing circadian rhythms, thus improving overall outcomes.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults ( more than 18 years).
- •Expected ICU stay more than 48 hours.
- •Informed consent obtained from patient or legal guardian.
排除标准
- •ICU admission more than 48 hours at the time of screening.
- •Unable to assess for delirium (eg, coma or deep sedation; receiving neuromuscular blocking drugs) at the time of screening.
- •History of severe cognitive or neurodegenerative disease (eg, dementia, Parkinson’s disease) or severe structural brain injury (eg, traumatic brain injury, intracranial haemorrhage.
- •Severe hepatic or renal dysfunction.
- •Known allergy to melatonin.
- •Absolute contradiction to enteral nutrition (eg, gastrointestinal obstruction,perforation,recent gastrointestinal surgery,deemed strict nil by mouth,lack of enteral access).
- •Pregnant and lactating women.
- •Active seizures.
研究者
Dr DEBASISH GHOSH
MEDICAL COLLEGE AND HOSPITAL,KOLKATA