CompletedPhase 4

Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion

United States68 participantsStarted 2009-06

Plain-language summary

Major lumbar spine surgery causes inflammation, soreness and swelling that can delay discharge from the hospital. Dexmedetomidine (DEX) has been shown to have anti-inflammatory effects. This study will evaluate whether DEX can help get patients out of the hospital faster after major spine surgery by reducing the inflammation associated with the procedure itself. A separate part of the study will evaluate the blood levels of some specific indicators of inflammation called cytokines. Measuring cytokines before and after surgery will aid in determining if DEX has altered the inflammatory response.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion Criteria: * American Society of Anesthesiologists (ASA) Classification I - III * Scheduled for Open Posterior Lumbar Fusion over 3+ (bony) levels Exclusion Criteria: * Allergy to dexmedetomidine * Cardiac disease with reduced ejection fraction \< 30% * History of cirrhosis, active hepatitis or attenuated hepatic function * Chronic use of steroids, COX-2 inhibitors, alpha-2 agonists, or statins * Current anticoagulant therapy * Patients requiring motor evoked potential (MEP) monitoring * Positive pregnancy test

What they're measuring

Time Required After Surgery to Reach Fitness for Discharge From Hospital

Timeframe: Start of study drug to time to reach fitness for discharge from hospital (about 3 to 5 days)

Trial details

NCT IDNCT00808665

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

Results submitted2017-06-20

View on ClinicalTrials.gov More Spinal Fusion Acquired trials