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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377623
• Other study ID #: 10-02185
• Status: Completed
• Phase: N/A
• First received: January 3, 2011
• Last updated: January 26, 2015
• Start date: September 2010
• Est. completion date: June 2012

Study information

• Verified date: January 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammation
• Spinal Stenosis

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York
United States	NYU Langone Medical Center, Department of Anesthesiology	New York City	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Hospira, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.0b013e318 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of cytokines (TNF-alpha, IL-1Beta, IL-2, IL-6, IL-10, IFN-gamma) at different time points will be our primary outcome.		Change from baseline cytokin levels	No
Secondary	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.		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.	No