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

University of California, San Diego120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

120

Conditions

Delirium Sleep Deprivation

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Duration of Delirium

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

Time frame: 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.

Time frame: Daily for up to 10 days

Secondary Outcomes

Number of Participants With Delirium

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

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.

Time frame: 10 days

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

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

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.

Time frame: 3 days