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Effect of Dexmedetomidine Upon Sleep Postoperatively
This study is currently recruiting participants.
Verified by Duke University, July 2006
Sponsored by: Duke University
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00333632
  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 IV

Drug Information available for: Fentanyl Citrate Fentanyl Midazolam Midazolam hydrochloride Midazolam maleate Propofol Dexmedetomidine Dexmedetomidine hydrochloride Isoflurane
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title: Restorative Sleep: Effect of Dexmedetomidine

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.

Estimated Enrollment: 60
Study Start Date: June 2006
Estimated Study Completion Date: June 2007
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

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333632

Contacts
Contact: Keita Ikeda, PhD 919-812-5043 ikeda002@mc.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: David B MacLeod, MD     919-681-6437     david.macleod@duke.edu    
Contact: Keita Ikeda, PhD     919-812-5043     ikeda002@mc.duke.edu    
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: David B MacLeod, MD Duke University
  More Information

Study ID Numbers: 8306
Study First Received: June 2, 2006
Last Updated: July 19, 2006
ClinicalTrials.gov Identifier: NCT00333632  
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Sleep
Dexmedetomidine
Postoperative care
Sedation

Study placed in the following topic categories:
Fentanyl
Isoflurane
Dexmedetomidine
Propofol
Midazolam

Additional relevant MeSH terms:
Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Adrenergic Agonists
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 13, 2009