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Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion

This study has been terminated.
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01377623
First received: January 3, 2011
Last updated: October 24, 2016
Last verified: October 2016

January 3, 2011
October 24, 2016
September 2010
January 2012   (Final data collection date for primary outcome measure)
Quality of Recovery Score (QoR-40) [ Time Frame: Post-operative Day 3 ]
The QoR-40 is a 40 item questionnaire in which each question is answered with a score of 1-5. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Concentration of cytokines (TNF-alpha, IL-1Beta, IL-2, IL-6, IL-10, IFN-gamma) at different time points will be our primary outcome. [ Time Frame: Change from baseline cytokin levels in post op day 1,2,3. ]
Complete list of historical versions of study NCT01377623 on ClinicalTrials.gov Archive Site
  • Concentration of TNF-alpha [ Time Frame: Post-operative Day 1 ]
  • Concentration of IL-1a [ Time Frame: Post-operative Day 1 ]
  • Concentration of IL-6 [ Time Frame: Post-operative Day 1 ]
  • Concentration of IL-8 [ Time Frame: Post-operative Day 1 ]
The secondary outcome parameters would be the quality of recovery score (QoR-40) to measure quality of recovery from surgery and a simple fatigue scale. [ Time Frame: Up to 2 weeks before the day of the surgery. On post-operative day 1, 2, 3. And phone follow-ups on day 30 and day 90 after the surgery. ]
Not Provided
Not Provided
 
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
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.

Surgical injury to tissue causes a variety of profound physiologic reactions which are essential for the restoration of an organisms' homeostasis. The inflammatory response involves a surge of stress hormones (i.e. ACTH, cortisol, catecholamines), activation of the complement system, migration of leukocytes to the site of injury, the release of cytokines (i.e. interleukins, tumor necrosis factor), as well as other cellular products (i.e. superoxide radicals, proteases, growth factors) (1-3). An appropriate inflammatory cascade is essential for tissue reconstitution and infection control. The associated impairment of multiple organ function is generally mild, because of the physiological reserve of the biological systems. However, a systemic inflammatory response may also lead to postoperative complications in the elderly, neonates, and patients with significant co-morbidity (4, 5). Indeed, mediators of inflammation may induce fatigue and prolong convalescence in healthy patients. On the other hand, dysregulation or suppression of the inflammatory process may lead to improper wound healing, infection and, as demonstrated recently, even an increase in cancer recurrence due to reduction in natural killer cell activity (6, 7).

Anesthetic management may affect both immunostimulatory and immunosuppressive mechanisms either directly by modulating functions of immune cells or indirectly by attenuating the stress response. For example, inhalational anesthetics inhibit neutrophil function and depress lymphocyte proliferation while increasing pro-inflammatory cytokine levels (8, 9)). Propofol also inhibits neutrophil and monocyte function, and has strong anti-inflammatory and anti-oxidative effects (10). Opioids attenuate the direct cell immune response, but have only minimal effects on systemic inflammatory responses (11). It is expected that the choice of anesthetic technique may disturb the balance between pro- and anti-inflammatory responses thus affecting clinical outcomes. A most advantageous anesthetic choice would enhance or have a neutral effect on cellular immunity while minimizing contribution to the systemic inflammatory response.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Spinal Stenosis
  • Inflammation
  • Device: Dexmedetomidine group
    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).
  • Device: Placebo group
    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).
  • Placebo Comparator: Placebo group
    Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
    Intervention: Device: Placebo group
  • Experimental: Dexmedetomidine group
    Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
    Intervention: Device: Dexmedetomidine group
Bekker A, Haile M, Kline R, Didehvar S, Babu R, Martiniuk F, Urban M. The effect of intraoperative infusion of dexmedetomidine on the quality of recovery after major spinal surgery. J Neurosurg Anesthesiol. 2013 Jan;25(1):16-24. doi: 10.1097/ANA.0b013e31826318af.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
66
January 2012
January 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01377623
10-02185
No
Not Provided
Yes
Not Provided
New York University School of Medicine
New York University School of Medicine
Hospira, Inc.
Principal Investigator: Alex Bekker, MD, PhD NYU School of Medicine
Principal Investigator: Michael Urban, MD Hospital for Special Surgery, New York
New York University School of Medicine
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP