Usage of Baclofen for Sleep Improvement After Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Polysomnography (quantity & quality of sleep)
研究概览
简要总结
Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac surgery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective cardiac surgery
排除标准
- •Haemodynamic instability
- •Psychotic disturbances
- •Acute / Chronic respiratory failure
- •Morbid obesity (BMI > 45 kg/m2)
- •Sleep apnea (treated)
- •Severe hepatic or renal failure
- •Patient refusal
研究组 & 干预措施
Baclofen
Baclofen 25 mg per os for 7 days at 10 pm every day
干预措施: Baclofen (Drug)
Placebo
Placebo per os for 7 days at 10 pm every day
干预措施: Placebo (Drug)
结局指标
主要结局
Polysomnography (quantity & quality of sleep)
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Sleep assessment by polysomnography
次要结局
未报告次要终点