Effect of Dexmedetomidine Upon Sleep Postoperatively

Restorative Sleep: Effect of Dexmedetomidine

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.

Study Overview

• Status: Withdrawn
• Conditions: Sleep
• Intervention / Treatment: Drug: Fentanyl; Drug: Dexmedetomidine; Drug: Midazolam; Drug: Propofol; Drug: Isoflurane

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: David B MacLeod, MD, Duke University

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 2, 2006
• First Submitted That Met QC Criteria: June 2, 2006
• First Posted (Estimate): June 6, 2006

Study Record Updates

• Last Update Posted (Estimate): July 14, 2014
• Last Update Submitted That Met QC Criteria: July 11, 2014
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Postoperative care; Sleep; Sedation; Dexmedetomidine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics, Inhalation; Fentanyl; Midazolam; Propofol; Dexmedetomidine; Isoflurane
• Other Study ID Numbers: Pro00007964; 8306 (Other Identifier: Inonu University)