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Effect of Dexmedetomidine Upon Sleep Postoperatively

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00333632
Recruitment Status : Withdrawn
First Posted : June 6, 2006
Last Update Posted : July 14, 2014
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sleep Drug: Dexmedetomidine Drug: Propofol Drug: Midazolam Drug: Fentanyl Drug: Isoflurane Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Restorative Sleep: Effect of Dexmedetomidine
Study Start Date : June 2006
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Measurements of sleep quality during postoperative period:Epworth Sleepiness Scale
  2. Completion of sleep log
  3. Subjects will also be asked to complete Visual Analogue Scales (VAS) of sleep and daytime sleepiness.

Secondary Outcome Measures :
  1. The quality of postoperative recovery (QoR) and the presence of fatigue (Brief Fatigue Inventory)
  2. Subjects will also be asked to complete Visual Analogue Scale (VAS) of fatigue.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00333632

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Principal Investigator: David B MacLeod, MD Duke University

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Responsible Party: Duke University Identifier: NCT00333632    
Other Study ID Numbers: Pro00007964
8306 ( Other Identifier: Duke legacy protocol number )
First Posted: June 6, 2006    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: June 2011
Keywords provided by Duke University:
Postoperative care
Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Anesthetics, Inhalation