Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01377441
First received: June 17, 2011
Last updated: November 12, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01377441     History of Changes
Other Study ID Numbers: 11-01188
Study First Received: June 17, 2011
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 24, 2014