Effect of Dexmedetomidine Upon Sleep Postoperatively

Sleep Clinical Trial

Official title:

Restorative Sleep: Effect of Dexmedetomidine

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00333632
• Other study ID #: Pro00007964
• Secondary ID: 8306
• Status: Withdrawn
• Phase: Phase 4
• First received: June 2, 2006
• Last updated: July 11, 2014
• Start date: June 2006
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep

Intervention

Drug:
• Dexmedetomidine

• Propofol

• Midazolam

• Fentanyl

• Isoflurane

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of sleep quality during postoperative period:Epworth Sleepiness Scale
Primary	Completion of sleep log
Primary	Subjects will also be asked to complete Visual Analogue Scales (VAS) of sleep and daytime sleepiness.
Secondary	The quality of postoperative recovery (QoR) and the presence of fatigue (Brief Fatigue Inventory)
Secondary	Subjects will also be asked to complete Visual Analogue Scale (VAS) of fatigue.