Effect of Dexmedetomidine Upon Sleep Postoperatively
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|ClinicalTrials.gov Identifier: NCT00333632|
Recruitment Status : Withdrawn
First Posted : June 6, 2006
Last Update Posted : July 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Sleep||Drug: Dexmedetomidine Drug: Propofol Drug: Midazolam Drug: Fentanyl Drug: Isoflurane||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Restorative Sleep: Effect of Dexmedetomidine|
|Study Start Date :||June 2006|
|Actual Study Completion Date :||June 2011|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333632
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||David B MacLeod, MD||Duke University|