Effect of Dexmedetomidine Upon Sleep Postoperatively

Sponsor

Duke University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00333632

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep	Drug: Dexmedetomidine Drug: Propofol Drug: Midazolam Drug: Fentanyl Drug: Isoflurane	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Restorative Sleep: Effect of Dexmedetomidine

Study Start Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2011

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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