Effect of Dexmedetomidine Upon Sleep Postoperatively

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00333632
First received: June 2, 2006
Last updated: September 12, 2013
Last verified: June 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

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

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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00333632     History of Changes
Other Study ID Numbers: Pro00007964 (8306)
Study First Received: June 2, 2006
Last Updated: September 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Sleep
Dexmedetomidine
Postoperative care
Sedation

Additional relevant MeSH terms:
Midazolam
Fentanyl
Propofol
Dexmedetomidine
Isoflurane
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Anesthetics, Inhalation
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists

ClinicalTrials.gov processed this record on April 14, 2014