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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: January 26, 2015
Last verified: January 2015
Results First Received: December 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Inflammatory Response
Interventions: Drug: Ibuprofen
Drug: Placebo/Saline solution

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from the perioperative area.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.

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

Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose.


Participant Flow:   Overall Study
    Ibuprofen     Placebo/Saline Solution  
STARTED     0     0  
COMPLETED     0 [1]   0 [1]
NOT COMPLETED     0     0  
[1] All data for this study was lost after Hurricane Sandy.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All data was lost after Hurricane Sandy.

Reporting Groups
  Description
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.

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.

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

Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose.

Total Total of all reporting groups

Baseline Measures
    Ibuprofen     Placebo/Saline Solution     Total  
Number of Participants  
[units: participants]
  0     0     0  
Age  
[units: participants]
     
<=18 years              
Between 18 and 65 years              
>=65 years              
Gender  
[units: participants]
     
Female              
Male              



  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Quality of Recovery Score (QoR-40).   [ Time Frame: 48h ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lisa Doan, MD
Organization: NYU School of Medicine
phone: 212.263.5072
e-mail: lisa.doan@nyumc.org



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
Results First Received: December 12, 2014
Last Updated: January 26, 2015
Health Authority: United States: Institutional Review Board