NCT00333632

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 14, 2014

Status Verified

June 1, 2011

First QC Date

June 2, 2006

Last Update Submit

July 11, 2014

Conditions

Sleep

Keywords

SleepDexmedetomidinePostoperative careSedation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • 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.

Interventions

DexmedetomidineDRUG
PropofolDRUG
MidazolamDRUG
FentanylDRUG
IsofluraneDRUG

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Sleep disturbance
  • Insomnia
  • Sleep apnea
  • Female (pregnant)
  • Contra-indication to placement of epidural anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

DexmedetomidinePropofolMidazolamFentanylIsoflurane

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPiperidinesMethyl EthersEthers

Study Officials

  • David B MacLeod, MD

    Duke University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

June 1, 2006

Study Completion

June 1, 2011

Last Updated

July 14, 2014

Record last verified: 2011-06

Locations

US(1)