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Effect of Dexmedetomidine Upon Sleep Postoperatively

Restorative Sleep: Effect of Dexmedetomidine

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00333632
Enrollment
0
Registered
2006-06-06
Start date
2006-06-30
Completion date
2011-06-30
Last updated
2014-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

Sleep, Dexmedetomidine, Postoperative care, Sedation

Brief 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.

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.

Interventions

DRUGDexmedetomidine
DRUGPropofol
DRUGMidazolam
DRUGFentanyl
DRUGIsoflurane

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026