Trials / Suspended
SuspendedNCT02529514
Usage of Baclofen for Sleep Improvement After Cardiac Surgery
- Status
- Suspended
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University of Liege · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Baclofen | 25 mg for 7 days at 10 pm every day |
| DRUG | Placebo | Placebo for 7 days at 10 pm every day |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2015-08-20
- Last updated
- 2016-05-13
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT02529514. Inclusion in this directory is not an endorsement.