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Effect of Dexmedetomidine Upon Sleep Postoperatively

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00333632
First Posted: June 6, 2006
Last Update Posted: July 14, 2014
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.
Information provided by (Responsible Party):
Duke University
  Purpose
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 Intervention Phase
Sleep Drug: Dexmedetomidine Drug: Propofol Drug: Midazolam Drug: Fentanyl Drug: Isoflurane Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Restorative Sleep: Effect of Dexmedetomidine

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 0
Study Start Date: June 2006
Study Completion Date: June 2011
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.

  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00333632


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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00333632     History of Changes
Other Study ID Numbers: Pro00007964
8306 ( Other Identifier: Duke legacy protocol number )
First Submitted: June 2, 2006
First Posted: June 6, 2006
Last Update Posted: July 14, 2014
Last Verified: June 2011

Keywords provided by Duke University:
Sleep
Dexmedetomidine
Postoperative care
Sedation

Additional relevant MeSH terms:
Propofol
Dexmedetomidine
Midazolam
Fentanyl
Isoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
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
Narcotics
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Anesthetics, Inhalation