Clinical trial NCT02691013: The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
Official title: The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium
Sleep Deprivation
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Duration of Delirium
timeFrame: Twice daily for up to 10 days
measure: Total Duration of Sleep
timeFrame: Daily for up to 10 days
Secondary outcomes:
measure: Number of Participants With Delirium
timeFrame: Twice daily for up to 10 days
measure: Average Daily Critical Care Pain Observation Tool (CPOT)
timeFrame: 10 days
measure: Length of Hospital Stay
timeFrame: Duration of hospital admission
measure: Length of ICU Stay
timeFrame: Duration of hospital admission
measure: Measures of Light Quality in the Patient's Room
timeFrame: 3 days
measure: Measures of the Sound Levels in the Patient's Room
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
affiliation: 8686577118
name: Robert Owens
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Aama T, Brymer C, Gutmanis I, Woolmore-Goodwin SM, Esbaugh J, Dasgupta M. Melatonin decreases delirium in elderly patients: a randomized, placebo-controlled trial. Int J Geriatr Psychiatry. 2011 Jul;26(7):687-94. doi: 10.1002/gps.2582. Epub 2010 Sep 15.
citation: Bellapart J, Boots R. Potential use of melatonin in sleep and delirium in the critically ill. Br J Anaesth. 2012 Apr;108(4):572-80. doi: 10.1093/bja/aes035.
citation: Hatta K, Kishi Y, Wada K, Takeuchi T, Odawara T, Usui C, Nakamura H; DELIRIA-J Group. Preventive effects of ramelteon on delirium: a randomized placebo-controlled trial. JAMA Psychiatry. 2014 Apr;71(4):397-403. doi: 10.1001/jamapsychiatry.2013.3320.
citation: Jaiswal SJ, Vyas AD, Heisel AJ, Ackula H, Aggarwal A, Kim NH, Kerr KM, Madani M, Pretorius V, Auger WR, Fernandes TM, Malhotra A, Owens RL. Ramelteon for Prevention of Postoperative Delirium: A Randomized Controlled Trial in Patients Undergoing Elective Pulmonary Thromboendarterectomy. Crit Care Med. 2019 Dec;47(12):1751-1758. doi: 10.1097/CCM.0000000000004004.