The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
- Registration Number
- NCT02691013
- Lead Sponsor
- University of California, San Diego
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) who are admitted to UCSD for a planned PTE surgery.
- Age > 18 years
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Patients will receive a Placebo tablet every evening. Ramelteon Ramelteon Patients will receive Ramelteon 8mg every evening.
- Primary Outcome Measures
Name Time Method Duration of Delirium Twice daily for up to 10 days Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.
Total Duration of Sleep 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Delirium Twice daily for up to 10 days Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument
Measures of the Sound Levels in the Patient's Room 3 days Sound meter was placed at bedside in each patient room. This meter measured and recorded the sound level in decibels every two seconds.
Average Daily Critical Care Pain Observation Tool (CPOT) 10 days average daily pain level using the CPOT Participants can score from 0 to 6 on the CPOT scale, with 0 being no pain (calm, comfortable), and 6 representing significant pain/agitation.
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 Light meter placed at bedside in patient room; this meter measured and recorded the light level in lux for ever minutes.