The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
Primary Purpose
Delirium, Sleep Deprivation
Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ramelteon
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Delirium
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Ramelteon
Arm Description
Patients will receive a Placebo tablet every evening.
Patients will receive Ramelteon 8mg every evening.
Outcomes
Primary Outcome Measures
Duration of Delirium
Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.
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.
Secondary Outcome Measures
Number of Participants With Delirium
Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument
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.
Length of Hospital Stay
Length of ICU Stay
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.
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.
Full Information
NCT ID
NCT02691013
First Posted
December 28, 2015
Last Updated
February 1, 2022
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT02691013
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Sleep Deprivation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive a Placebo tablet every evening.
Arm Title
Ramelteon
Arm Type
Active Comparator
Arm Description
Patients will receive Ramelteon 8mg every evening.
Intervention Type
Drug
Intervention Name(s)
Ramelteon
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Duration of Delirium
Description
Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.
Time Frame
Twice daily for up to 10 days
Title
Total Duration of Sleep
Description
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.
Time Frame
Daily for up to 10 days
Secondary Outcome Measure Information:
Title
Number of Participants With Delirium
Description
Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument
Time Frame
Twice daily for up to 10 days
Title
Average Daily Critical Care Pain Observation Tool (CPOT)
Description
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.
Time Frame
10 days
Title
Length of Hospital Stay
Time Frame
Duration of hospital admission
Title
Length of ICU Stay
Time Frame
Duration of hospital admission
Title
Measures of Light Quality in the Patient's Room
Description
Light meter placed at bedside in patient room; this meter measured and recorded the light level in lux for ever minutes.
Time Frame
3 days
Title
Measures of the Sound Levels in the Patient's Room
Description
Sound meter was placed at bedside in each patient room. This meter measured and recorded the sound level in decibels every two seconds.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Owens
Organizational Affiliation
8686577118
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20845391
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. Erratum In: Int J Geriatr Psychiatry. 2014 May;29(5):550.
Results Reference
background
PubMed Identifier
22419624
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.
Results Reference
background
PubMed Identifier
24554232
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.
Results Reference
background
PubMed Identifier
31567351
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.
Results Reference
derived
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The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
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