Phase 4
N=63
Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion
Spinal Fusion Acquired · Spinal Stenosis · Lesions of Lumbosacral Intervertebral Disc · Spinal Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00808665 ↗Enrolled (actual)
63
Serious AEs
6.5%
Results posted
May 2018
Primary outcome: Primary: Time Required After Surgery to Reach Fitness for Discharge From Hospital — 3.2; 3.2 days — p=0.36
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine (Drug); 0.9% Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Required After Surgery to Reach Fitness for Discharge From Hospital |
3.2; 3.2 | 0.36 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00808665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.