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Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
This study is currently Recruiting
June 2011 By New York University School of Medicine
First Recieved on January 3, 2011
Last Updated on September 12, 2011
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.
||Observational Model: Cohort, Time Perspective: Prospective
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
Fifty six subjects (28 in each arm) will be enrolled. Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
1. Adult (> 18) male or female who will undergo surgery for spinal fusion with general
2. 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.
3. Subject is ASA physical status 1, 2, or 3.
1. Cognitively impaired (by history)
2. Subject requires chronic antipsychotic history
3. Subject is anticipated to require an additional surgery within 90 days after the
intended spinal fusion
4. Subject known to be in liver failure
5. Subject has received treatment with alpha-2-agonist or antagonist within 2 weeks of
6. Subject for whom opiates, benzodiazepines, DEX are contraindicated
7. Chronic use of steroids/NSAIDs
8. Patients with serious bradycardia related arrhythmias, i.e. 2nd degree block.
- Investigator: Alex Bekker, MD, PhD - Principal Investigator - NYU School of Medicine
- Investigator: Michael Urban, MD - Principal Investigator - Hospital for Special Surgery, New York
- Hospital for Special Surgery
New York, New York 10021 United States
- NYU Langone Medical Center, Department of Anesthesiology
New York City, New York 10016 United States