The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- Duration of Delirium
研究概览
简要总结
Sleep deprivation is known to affect brain function but is often ignored in the sickest patients including those in the intensive care unit after major surgery. In these patients, the levels of melatonin can also be altered. Melatonin is a hormone secreted in the brain that maintains the body's sleep-wake, or circadian, cycle. The investigators want to test whether improving sleep quality affects the risk of developing confusion (delirium) in patients having clot removed from their lung (open heart surgery). In order to improve sleep quality, the investigators will conduct a study of Ramelteon, a medication that mimics the activity of melatonin and measure its effects on levels of melatonin and monitor sleep.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) who are admitted to UCSD for a planned PTE surgery.
- •Age > 18 years
排除标准
- •Pregnancy
- •Cirrhosis of any etiology
- •Current use of any atypical antipsychotic including Fluvoxamine (contra-indicated with Ramelteon)
- •Any contraindication to EEG/Sleep recording
- •Non-English speaking (who are unable to complete delirium questionnaires)
研究组 & 干预措施
Placebo
Patients will receive a Placebo tablet every evening.
干预措施: Placebo (Drug)
Ramelteon
Patients will receive Ramelteon 8mg every evening.
干预措施: Ramelteon (Drug)
结局指标
主要结局
Duration of Delirium
时间窗: Twice daily for up to 10 days
Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.
Total Duration of Sleep
时间窗: Daily for up to 10 days
Participants wore an actigraphy device on their wrist for the duration of their ICU stay. This device continuously measures activity, and thus estimates sleep time.
次要结局
- Number of Participants With Delirium(Twice daily for up to 10 days)
- Measures of the Sound Levels in the Patient's Room(3 days)
- Average Daily Critical Care Pain Observation Tool (CPOT)(10 days)
- Length of Hospital Stay(Duration of hospital admission)
- Length of ICU Stay(Duration of hospital admission)
- Measures of Light Quality in the Patient's Room(3 days)
研究者
Robert L. Owens
Associate Professor, Pulmonary, Critical Care and Sleep Medicine
University of California, San Diego