Usage of Baclofen for Sleep Improvement After Cardiac Surgery

University of Liege

Status and phase: Suspended; Phase 4

Conditions: Sleep

Treatments: Drug: Baclofen; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02529514

Baclo-Sleep

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Baclofen

Active Comparator group

Description:

Baclofen 25 mg per os for 7 days at 10 pm every day

Treatment:

Drug: Baclofen

Placebo

Placebo Comparator group

Description:

Placebo per os for 7 days at 10 pm every day

Treatment:

Drug: Placebo