The Effect of General Versus Regional Anesthesia on Postoperative Sleep Quality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index)
研究概览
简要总结
Major surgery can lead to postoperative disturbances in sleep patterns with subjective deterioration of sleep quality according to patients' reports as well as objective alterations of sleep architecture, as recorded by polysomnography Factors implicated in postoperative sleep disturbances include but are not limited to the severity of the surgical procedure, the neuroendocrine response to surgery, inadequate treatment of postoperative pain and external factors interfering with sleep, such as light, noise and therapeutic procedures There are no adequate data from current literature as to whether regional anesthesia is superior to general anesthesia regarding postoperative sleep quality in patients subjected to either mode of anesthesia. So, the aim of this study will be to assess the effect of two different anesthetic techniques (general versus regional) in patients subjected to similar operations Patients will be assessed with the Pittsburgh Sleep Quality Questionnaire (PSQI), regarding preoperative and long term postoperative sleep quality and sleep diaries regarding early postoperative sleep quality
详细描述
Major surgery can lead to postoperative disturbances in sleep patterns with subjective deterioration of sleep quality according to patients' reports as well as objective alterations of sleep architecture, as recorded by polysomnography.
These disturbances include severe sleep fragmentation, rapid eye movement (REM) and slow wave sleep significant reductions in duration as well as an increase in non-REM sleep stages. Spontaneous awakenings are also frequently reported.
After the third or fourth postoperative day, there is a substantial rebound in total REM activity, with frequent reports of vivid nightmares.
Factors implicated in postoperative sleep disturbances include but are not limited to the severity of the surgical procedure, the neuroendocrine response to surgery, inadequate treatment of postoperative pain and external factors interfering with sleep, such as light, noise and therapeutic procedures.
There are no adequate data from current literature as to whether regional anesthesia is superior to general anesthesia regarding postoperative sleep quality in patients subjected to either mode of anesthesia. There have been a few studies evaluating the effect of regional anesthesia on postoperative sleep quality after orthopedic procedures, without however comparing regional to general anesthesia in this setting. preliminary data from these studies suggest that regional anesthesia can also lead to postoperative sleep disturbances during the first postoperative nights, such as causing a reduction of REM stage.
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
- Single (Outcomes Assessor)
盲法说明
The investigator completing the questionnaires will not be aware of patient group assignment
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for saphenectomy
排除标准
- •Alcoholism
- •Mental disability
- •Psychiatric disease (depression, dementia)
- •Preoperative use of sleeping medication
- •Language barriers
- •Lack of informed consent
结局指标
主要结局
subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index)
时间窗: preoperative status, three months postoperatively
change from preoperative status of subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index) at three months postoperatively
次要结局
- sleep diary(first postoperative week)
研究者
Dr Kassiani Theodoraki
Associate Professor of Anesthesiology
Aretaieion University Hospital