The Influence of Short Term Treatment With Benzodiazepine After Cardiac Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 主要终点
- Assessing chronic insomnia
研究概览
简要总结
The study deals with the prevalence of insomnia after heart surgery and the outcome of treatment with Benzodiazepine for this phenomena.
详细描述
Patients after heart surgery develop sleep disorder in the form of Insomnia. This finding is known and described in the literature with respect to a large number of major operations such as the pneumonectomy, esophageal resection, pancreatic surgery, liver surgery and so on. In the general population, Insomnia is a common disorder and describe in more than 50% in adults over the age of 50. In patients with comorbidity among other things, heart disease indicates a rate of up to 85% of chronic insomnia. The reasons for insomnia after multiple heart surgery, including emotional stress that accompanies the patient after surgery, pain and prolonged hospitalization in the hospital. In this study, aim to compare the results of short-term treatment with sleep medication after heart surgery on morbidity and immediate recovery. This study will allow us to examine the effect of sleep medication therapy in patients receiving treatment compared to patients who did not receive treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older.
- •Applicants hospital for open heart surgery
排除标准
- •patients who came to emergency heart surgery.
- •patients who are not hemodynamically or respiratory stable
- •Patients who were taking hypnotic drugs on a daily basis before surgery.
- •Patients with low compliance that will not be able to fill out a sleep diary
- •lactose intolerance (due to components placebo)
- •Patients who can not take medication by one or more of the following:
- •pregnant.
- •Patients with severe respiratory insufficiency
- •Patients with liver failure.
- •Patients who are addicted to alcohol
- •Patients without psychiatric background.
研究组 & 干预措施
benzodiazepine
The patient which will be in the Experimental arm (after randomization) will receive 0.25 mg of Brotizolam (short acting benzodiazepine) for six weeks from the day of discharge.
干预措施: Brotizolam (Drug)
placebo
The patient which will be in the placebo arm (after randomization) will receive placebo for six weeks from the day of discharge.
干预措施: placebo (Drug)
结局指标
主要结局
Assessing chronic insomnia
时间窗: 1 year
The following outcome will be evaluated by Pittsburgh sleep quality index questionnaire before heart surgery.
次要结局
- Reducing insomnia in post cardiac surgery(1 year)