IRCT20191105045342N1招募中3 期
The effect of oral melatonin on sleep quality of hospitalized patients in the intensive care unit
Gonabad University of Medical Sciences0 个研究点目标入组 70 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 60 years（—）
- 性别
- All
入选标准
- •Glasgow Coma Scale (GCS) score =10
- •patients with stable hemodynamic
- •patients with out alcohol consumption =50 units per week or drug use(addiction) / narcotic or sedation drug order in icu
- •haven't been used of drugs that might alter melatonin secretion and decrease plasma levels of melatonin, such as benzodiazepines, NSAIDs, corticosteroids, beta-blockers, haloperidol and amiodarone / sedation with propofol, morphine, alfentanil and dexmedetomidine has been discontinued for a minimum of 36 hours (48 hours for lorazepam and midazolam) before enter to study
- •Apache II score < 35 and Estimated mortality < 75%
- •patients with out severe pain level (pain score > 7 on the numerical scale of pain) for one hour before the prescribe of melatonin
- •patients with out history of convulsions, psychiatric or neurological disease, deafness or blindness and the lack of any kind of sleep disorder such as sleep apnea, narcolepsy, chronic insomnia, restless legs syndrome (RLS)
- •patients with out liver insufficiency and renal insufficiency (requires dialysis)
- •patients with out severe heart failure (the New York Heart Association classification III/IV)
- •patients with out intestinal obstruction, ileus or other conditions likely to affect the enteral absorption of melatonin
- •Do not be pregnant or breast-feeding women
- •more than 24 hours have passed from general anesthesia or hospitalization
- •age =18 years old and = 60 years old
排除标准
- •The incidence of gastrointestinal failure that prevents the absorption of melatonin, including obstruction and ileus
- •The incidence of renal insufficiency (requires dialysis)
- •The incidence of any kind of sleep disorder such as sleep apnea, narcolepsy over night sleep
- •Pain scores above 7 on the numerical scale of pain during the intervention
- •Lack of willingness to cooperate in the study
研究者
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