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

University of California San Diego logo

University of California San Diego

Status

Active, not recruiting

Conditions

Delirium
Sleep Deprivation

Treatments

Drug: Placebo
Drug: Ramelteon

Study type

Interventional

Funder types

Other

Identifiers

NCT02691013
151294

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Patients will receive a Placebo tablet every evening.
Treatment:
Drug: Placebo
Ramelteon
Active Comparator group
Description:
Patients will receive Ramelteon 8mg every evening.
Treatment:
Drug: Ramelteon

Trial documents
1

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems