The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) who are admitted to UCSD for a planned PTE surgery.
- Age > 18 years
Exclusion criteria
- 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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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