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Randomized, Double-blind, Pilot Study on the Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia: Correlation With Clinical Outcomes


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Inflammatory Response

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Trial Information

Randomized, Double-blind, Pilot Study on the Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia: Correlation With Clinical Outcomes


Human and animal studies suggest cyclooxygenase-inhibitors (COX-inhibitors) decrease the
production of inflammatory mediators. Studies also suggest that COX inhibitors attenuate
increases in corticosterone and eicosanoid levels after endotoxin injection. COX inhibitors
also appear to have anticancer effects, inhibiting angiogenesis, tumor growth, and
metastatic burden. These results suggest a role for IV ibuprofen in preventing untoward
inflammatory responses, shortening post-surgical convalescence, improving patient
satisfaction, and reducing the rate of complications occurring during the recovery from
surgery. However, there are no studies that have evaluated the relationship between
administration of IV ibuprofen, ensuing immunomodulation, and long-term outcomes.

Study Objective. The aim of the proposed study is to examine the effect of intravenous(IV)
ibuprofen on the inflammatory response in major surgery. More importantly, the investigators
will correlate changes in the concentration of inflammatory mediators with meaningful
clinical outcomes.


Inclusion Criteria:



1. Adults, 18 and over, who will undergo surgery lasting longer than one hour with
general anesthesia

2. 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 surgery

4. Chronic use of steroids or opioids

5. Subject has received treatment with COX inhibitors within 3 days of study entry

6. Subject for whom opiates, benzodiazepines, and COX inhibitors are contraindicated

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

Concentrations of the cytokines tumor necrosis factor alpha (TNF-alpha), interleukin IL-1Beta (IL-1Beta), IL-2, IL-6, IL-10, and interferon-gamma (IFN-gamma) as well as prostaglandin E2 at different time points.

Outcome Description:

Concentration of the cytokines TNF-alpha, IL-1Beta, IL-2, IL-6, IL-10, and IFN-gamma as well as prostaglandin E2 at different time points will be our primary outcome. Changes in mediator levels in the IV ibuprofen versus placebo groups will be compared. Plasma samples will be collected before administration of any drug (after placement of IV lines), at the end of the surgery, and on the first postoperative day.

Outcome Time Frame:

48h

Safety Issue:

No

Principal Investigator

Lisa Doan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NYU Langone Medical Center

Authority:

United States: Institutional Review Board

Study ID:

11-01188

NCT ID:

NCT01377441

Start Date:

September 2011

Completion Date:

July 2013

Related Keywords:

  • Inflammatory Response
  • Ibuprofen
  • Cytokines
  • Recovery
  • IV ibuprofen
  • major surgery

Name

Location

NY Methodist HospitalBrooklyn, New York  11215
NYU Langone Medical CenterNew York, New York  10016