The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery

Delirium Clinical Trial

Official title:

The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02691013
• Other study ID #: 151294
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 1, 2022
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Delirium
• Sleep Deprivation

Intervention

Drug:
• Ramelteon

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

References & Publications (3)

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. Erratum in: Int J Geriatr Psychiatry. 2014 May;29(5):550. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Delirium	Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.	Twice daily for up to 10 days
Primary	Total Duration of Sleep	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.	Daily for up to 10 days
Secondary	Number of Participants With Delirium	Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument	Twice daily for up to 10 days
Secondary	Average Daily Critical Care Pain Observation Tool (CPOT)	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.	10 days
Secondary	Length of Hospital Stay		Duration of hospital admission
Secondary	Length of ICU Stay		Duration of hospital admission
Secondary	Measures of Light Quality in the Patient's Room	Light meter placed at bedside in patient room; this meter measured and recorded the light level in lux for ever minutes.	3 days
Secondary	Measures of the Sound Levels in the Patient's Room	Sound meter was placed at bedside in each patient room. This meter measured and recorded the sound level in decibels every two seconds.	3 days