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Clinical Trial Summary

Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac surgery.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02529514
Study type Interventional
Source University Hospital of Liege
Contact
Status Suspended
Phase Phase 4
Start date July 2015
Completion date June 2016

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