Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia.

NYU Langone Health

Status and phase: Terminated; Phase 4

Conditions: Inflammatory Response

Treatments: Drug: Placebo/Saline solution; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT01377441

11-01188

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6 participants in 2 patient groups, including a placebo group

Ibuprofen

Experimental group

Description:

Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.

Treatment:

Drug: Ibuprofen

Placebo/Saline solution

Placebo Comparator group

Description:

Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo

Treatment:

Drug: Placebo/Saline solution