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

NCT02691013 | Unknown Results

• 1 other identifier: 151294
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Delirium; Sleep Deprivation

Outcome Measures

Primary Outcomes (2)

• Duration of Delirium

  Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.

  Twice daily for up to 10 days

• 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 Outcomes (6)

• Number of Participants With Delirium

  Twice daily for up to 10 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients will receive a Placebo tablet every evening.

Drug: Placebo

Ramelteon

ACTIVE COMPARATOR

Patients will receive Ramelteon 8mg every evening.

Drug: Ramelteon

Interventions

Ramelteon DRUG

Ramelteon

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) who are admitted to UCSD for a planned PTE surgery.
• Age \> 18 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead

Related Publications (5)

• 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.

  PMID: 20845391 BACKGROUND

• 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.

  PMID: 22419624 BACKGROUND

• 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.

  PMID: 24554232 BACKGROUND

• Jaiswal SJ, Bagsic SRS, Takata E, Kamdar BB, Ancoli-Israel S, Owens RL. Actigraphy-based sleep and activity measurements in intensive care unit patients randomized to ramelteon or placebo for delirium prevention. Sci Rep. 2023 Jan 26;13(1):1450. doi: 10.1038/s41598-023-28095-0.

  PMID: 36702822 DERIVED

• 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.

  PMID: 31567351 DERIVED

MeSH Terms

Conditions

Delirium; Sleep Deprivation

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyssomnias; Sleep Wake Disorders

Results Point of Contact

• Title: Dr. Robert Owens
• Organization: University of California San Diego

rowens@ucsd.edu

858-657-5258

Study Officials

• Robert Owens

  8686577118

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pulmonary, Critical Care and Sleep Medicine

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: February 24, 2016
• Study Start: February 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 1, 2022
• Last Updated: February 8, 2022
• Results First Posted: September 20, 2019

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share