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

NCT ID: NCT01377441

Last Updated: 2017-12-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-05-31

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.

Conditions

Inflammatory Response

Keywords

Ibuprofen; Cytokines; Recovery; IV ibuprofen; major surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ibuprofen

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.

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

Patients will receive either 800mg IV ibuprofen or placebo pre-operatively. Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose.

Placebo/Saline solution

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

Group Type: PLACEBO_COMPARATOR

Placebo/Saline solution

Intervention Type: DRUG

Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose.

Interventions

Ibuprofen

Patients will receive either 800mg IV ibuprofen or placebo pre-operatively. Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose.

Intervention Type: DRUG

Placebo/Saline solution

Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose.

Intervention Type: DRUG

Other Intervention Names

nonsteroidal anti-inflammatory drug (NSAID)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Doan, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

NY Methodist Hospital

Brooklyn, New York, United States

NYU Langone Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

11-01188

Identifier Type: -

Identifier Source: org_study_id