Sleep
Conditions
Keywords
Baclofen, Cardiac Surgery, Polysomnography, Intensive Care Units, Sleep
Brief summary
Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac surgery.
Detailed description
This is a prospective randomized single-blind study involving patients adults admitted to the University Hospital of Liege for a scheduled heart surgery. The study is based on the oral administration of baclofen (or placebo) the evening Bedrooms (10 pm). This administration begins the day before surgery and ends 5th day after. Sleep is evaluated by various questionnaires at baseline, during the protocol and the end. In addition, a 24 polysomnography is performed the day after surgery.
Interventions
DRUGBaclofen
25 mg for 7 days at 10 pm every day
DRUGPlacebo
Placebo for 7 days at 10 pm every day
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective cardiac surgery
Exclusion criteria
* Haemodynamic instability * Epilepsy * Psychotic disturbances * Acute / Chronic respiratory failure * Morbid obesity (BMI \> 45 kg/m2) * Sleep apnea (treated) * Severe hepatic or renal failure * Patient refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polysomnography (quantity & quality of sleep) | Participants will be followed for the duration of hospital stay, an expected average of 10 days | Sleep assessment by polysomnography |
Countries
Belgium
Outcome results
None listed