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

This study has been terminated.
(Samples lost during Hurricane Sandy. Study now taking place at other medical centers.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01377441
First Posted: June 21, 2011
Last Update Posted: February 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose
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.

Condition Intervention Phase
Inflammatory Response Drug: Ibuprofen Drug: Placebo/Saline solution Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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. [ Time Frame: 48h ]
    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.


Secondary Outcome Measures:
  • Quality of Recovery Score (QoR-40). [ Time Frame: 48h ]
    The secondary outcome parameters will be the quality of recovery score (QoR-40) to measure quality of recovery from surgery, a simple fatigue scale, digits forward and backward, and the global depression schedule. Forty questions in five dimensions will be scored by patients on a five-point Likert scale. Seven point fatigue scales (in- and out-patient) is often used to assess progress of recovery in head trauma patients. Metrics will be administered on at the baseline visit and or on the day of surgery and on postoperative days 1, 2, 4 and 6.


Enrollment: 6
Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: nonsteroidal anti-inflammatory drug (NSAID)
Placebo Comparator: 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
Drug: Placebo/Saline solution
Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377441


Locations
United States, New York
NY Methodist Hospital
Brooklyn, New York, United States, 11215
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Lisa Doan, MD NYU Langone Medical Center
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01377441     History of Changes
Other Study ID Numbers: 11-01188
First Submitted: June 17, 2011
First Posted: June 21, 2011
Results First Submitted: December 12, 2014
Results First Posted: December 22, 2014
Last Update Posted: February 9, 2015
Last Verified: January 2015

Keywords provided by New York University School of Medicine:
Ibuprofen
Cytokines
Recovery
IV ibuprofen
major surgery

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action