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

Completed · Phase 4 · Has a placebo group

Conditions studied: Spinal Fusion Acquired, Spinal Stenosis, Lesions of Lumbosacral Intervertebral Disc, Spinal Diseases

In brief

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.

Key facts

Study ID

NCT00808665

Run by

Vanderbilt University Medical Center

People needed

68

Starts

2009-06-01

Expected to finish

2012-12-01

Last updated by the study team

2018-05-25

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• American Society of Anesthesiologists (ASA) Classification I - III
• Scheduled for Open Posterior Lumbar Fusion over 3+ (bony) levels

You may not qualify if…

• 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

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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