The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Placebo
- Conditions
- Delirium
- Sponsor
- University of California, San Diego
- Enrollment
- 120
- Primary Endpoint
- Duration of Delirium
- Last Updated
- 4 years ago
Overview
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.
Investigators
Robert L. Owens
Associate Professor, Pulmonary, Critical Care and Sleep Medicine
University of California, San Diego
Eligibility Criteria
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)
Arms & Interventions
Placebo
Patients will receive a Placebo tablet every evening.
Intervention: Placebo
Ramelteon
Patients will receive Ramelteon 8mg every evening.
Intervention: Ramelteon
Outcomes
Primary Outcomes
Duration of Delirium
Time Frame: Twice daily for up to 10 days
Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.
Total Duration of Sleep
Time Frame: 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 Outcomes
- 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)