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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

Sponsor: New York University School of Medicine
Collaborators: Hospira, Inc.
Information provided by: New York University School of Medicine
Identifier: NCT01377623


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.

Study Type: Observational
Study Design: Observational Model: Cohort, Time Perspective: Prospective


Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Inclusion Criteria: 1. Adult (> 18) male or female who will undergo surgery for spinal fusion with general anesthesia. 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. Exclusion Criteria: 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 study entry 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

Conditions related to this trial:

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