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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:
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

June 17, 2011
November 12, 2013
September 2011
May 2013   (final data collection date for primary outcome 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. [ 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.
Same as current
Complete list of historical versions of study NCT01377441 on ClinicalTrials.gov Archive Site
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.
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 and a simple fatigue scale. Forty questions in five dimensions will be scored by patients on a five-point Likert scale.
Not Provided
Not Provided
 
Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia.
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Inflammatory Response
  • 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)
  • Drug: Placebo/Saline solution
    Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose.
  • 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.
    Intervention: Drug: Ibuprofen
  • 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
    Intervention: Drug: Placebo/Saline solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01377441
11-01188
Yes
New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: Lisa Doan, MD NYU Langone Medical Center
New York University School of Medicine
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP