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临床试验/NCT03843645
NCT03843645招募中不适用

The Effect of General Versus Regional Anesthesia on Postoperative Sleep Quality

Aretaieion University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年2月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
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

研究组 & 干预措施

general anesthesia group

Active Comparator

patients allocated to the general anesthesia group will be subjected to general anesthesia with sevoflurane (inhalational agent) used for maintenance

干预措施: general anesthesia (Procedure)

regional anesthesia group

Active Comparator

patients allocated to the regional anesthesia group will be subjected to combined spinal-epidural anesthesia with ropivacaine and fentanyl

干预措施: regional anesthesia (Procedure)

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

subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index)

时间窗: preoperative status, one month postoperatively

change from preoperative status of subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index) at one month postoperatively

次要结局

  • sleep diary(first postoperative week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Kassiani Theodoraki

Associate Professor of Anesthesiology

Aretaieion University Hospital

研究点 (1)

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