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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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.
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.
Lisa Doan, MD
NYU Langone Medical Center
United States: Institutional Review Board
|NY Methodist Hospital||Brooklyn, New York 11215|
|NYU Langone Medical Center||New York, New York 10016|