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临床试验/NCT00333632
NCT00333632撤回4 期

Restorative Sleep: Effect of Dexmedetomidine

Duke University2 个研究点 分布在 1 个国家开始时间: 2006年6月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
2
主要终点
Measurements of sleep quality during postoperative period:Epworth Sleepiness Scale

研究概览

简要总结

The purpose of this study is to determine whether an intravenous infusion of dexmedetomidine administered to surgical patients intra-operatively will improve the characteristics of sleep post-operatively.

详细描述

Physiological similarities exist between the anesthetized state and sleep. Pathways within the brain controlling sleep and wakefulness are also affected by anesthesia. One significant difference between the states of anesthesia and sleep is the ability to respond whenever a relatively mild stimulus is applied, e.g. verbal command or gently shaking. Interestingly, this feature of arousability is seen when dexmedetomidine is used for sedation but is absent when alternative intravenous anesthetic agents, e.g. propofol, are used to provide similar degree of sedation. Recent studies have shown that dexmedetomidine acts on receptors located within the locus ceruleus, which are responsible for both sleep and anesthesia.

During a recent study volunteers received an infusion of dexmedetomidine during the afternoon prior to remaining under study conditions for the duration of the night. The study was not designed to measure sleep but anecdotal reporting from the participants suggested that they were able to resume their normal day's activities whilst the subject receiving placebo felt extremely fatigued from lack of sleep. This prompted the establishment of a pilot study to determine if dexmedetomidine could provide restorative sleep to people under disturbed sleep conditions i.e. postoperative patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled to undergo elective lower extremity orthopaedic surgery (free vascular fibular graft)
  • ASA 1 or 2
  • Body Mass Index 20 - 30
  • Procedure to be done under combined epidural and general anesthesia

排除标准

  • Sleep disturbance
  • Sleep apnea
  • Female (pregnant)
  • Contra-indication to placement of epidural anesthesia

结局指标

主要结局

Measurements of sleep quality during postoperative period:Epworth Sleepiness Scale

Subjects will also be asked to complete Visual Analogue Scales (VAS) of sleep and daytime sleepiness.

Completion of sleep log

次要结局

  • The quality of postoperative recovery (QoR) and the presence of fatigue (Brief Fatigue Inventory)
  • Subjects will also be asked to complete Visual Analogue Scale (VAS) of fatigue.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Effect of Dexmedetomidine Upon Sleep Postoperatively | 临床试验