Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
Stopped early · Not applicable · Has a placebo group
Conditions studied: Spinal Stenosis, Inflammation
In brief
The aim of the proposed study is to examine the effect of DEX on the inflammatory response in major surgery. More importantly, the investigators will correlate changes in the concentration of inflammatory mediators with meaningful clinical outcomes.
Key facts
- Study ID
- NCT01377623
- Run by
- NYU Langone Health
- People needed
- 66
- Starts
- 2010-09-01
- Expected to finish
- 2012-01-01
- Last updated by the study team
- 2017-07-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult (> 18) male or female who will undergo surgery for spinal fusion with general anesthesia.
- If female, subject is non-lactating and is either:
- Not of childbearing potential
- Of childbearing potential but is not pregnant at time of baseline as determined by pre-surgical pregnancy testing.
- Subject is ASA physical status 1, 2, or 3.
You may not qualify if…
- Cognitively impaired (by history)
- Subject requires chronic antipsychotic history
- Subject is anticipated to require an additional surgery within 90 days after the intended spinal fusion
- Subject known to be in liver failure
- Subject has received treatment with alpha-2-agonist or antagonist within 2 weeks of study entry
- Subject for whom opiates, benzodiazepines, DEX are contraindicated
- Chronic use of steroids/NSAIDs
- Patients with serious bradycardia related arrhythmias, i.e. 2nd degree block.
Where it is running
- NYU Langone Medical Center, Department of Anesthesiology — New York, New York, United States
- Hospital for Special Surgery — New York, New York, United States
Full record on ClinicalTrials.gov
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