Usage of Baclofen for Sleep Improvement After Cardiac Surgery
- Registration Number
- NCT02529514
- Lead Sponsor
- University of Liege
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Elective cardiac surgery
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo per os for 7 days at 10 pm every day Baclofen Baclofen Baclofen 25 mg per os for 7 days at 10 pm every day
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Belgium