Clinical trial NCT01377441: Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia.
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Inflammatory Response
Keywords: Ibuprofen
Cytokines
Recovery
IV ibuprofen
major surgery
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2011-06-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The administration of anti-inflammatory drugs such as ibuprofen before and after surgery has not been studied extensively. Subjects are being asked to participate in this study because they are scheduled for surgery and because the investigators want to study ways to improve recovery from surgery. Ibuprofen will be given several times before and after surgery. The investigators will ask questions to determine recovery and the investigators will draw blood to determine inflammatory response.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 48h
Secondary outcomes:
measure: Quality of Recovery Score (QoR-40).
timeFrame: 48h
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: NY Methodist Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Lisa Doan, MD
role: PRINCIPAL_INVESTIGATOR
References: