The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
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|ClinicalTrials.gov Identifier: NCT02691013|
Recruitment Status : Active, not recruiting
First Posted : February 24, 2016
Results First Posted : September 20, 2019
Last Update Posted : December 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Delirium Sleep Deprivation||Drug: Ramelteon Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||December 1, 2021|
Placebo Comparator: Placebo
Patients will receive a Placebo tablet every evening.
Active Comparator: Ramelteon
Patients will receive Ramelteon 8mg every evening.
- 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.
- Number of Participants With Delirium [ Time Frame: Twice daily for up to 10 days ]Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument
- Average Daily Critical Care Pain Observation Tool (CPOT) [ Time Frame: 10 days ]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 [ Time Frame: Duration of hospital admission ]
- Length of ICU Stay [ Time Frame: Duration of hospital admission ]
- Measures of Light Quality in the Patient's Room [ Time Frame: 3 days ]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 [ Time Frame: 3 days ]Sound meter was placed at bedside in each patient room. This meter measured and recorded the sound level in decibels every two seconds.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691013
|Principal Investigator:||Robert Owens||8686577118|