Effect of Dexmedetomidine Upon Sleep Postoperatively
|Sleep||Drug: Dexmedetomidine Drug: Propofol Drug: Midazolam Drug: Fentanyl Drug: Isoflurane||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Restorative Sleep: Effect of Dexmedetomidine|
- Measurements of sleep quality during postoperative period:Epworth Sleepiness Scale
- Completion of sleep log
- Subjects will also be asked to complete Visual Analogue Scales (VAS) of sleep and daytime sleepiness.
- 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.
|Study Start Date:||June 2006|
|Study Completion Date:||June 2011|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333632
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||David B MacLeod, MD||Duke University|