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

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ClinicalTrials.gov Identifier: NCT01377441
Recruitment Status : Terminated (Samples lost during Hurricane Sandy. Study now taking place at other medical centers.)
First Posted : June 21, 2011
Results First Posted : December 22, 2014
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Inflammatory Response
Interventions Drug: Ibuprofen
Drug: Placebo/Saline solution
Enrollment 6
Recruitment Details Patients were recruited from the perioperative area.
Pre-assignment Details  
Arm/Group Title Ibuprofen Placebo/Saline Solution
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 0 0
Completed 0 [1] 0 [1]
Not Completed 0 0
[1]
All data for this study was lost after Hurricane Sandy.
Arm/Group Title Ibuprofen Placebo/Saline Solution Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
All data was lost after Hurricane Sandy.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame 48h
Hide Outcome Measure Data
Hide Analysis Population Description
Unfortunately, due to major flooding at our site, due to Hurricane Sandy, all data and samples for this study were lost. Therefore, it was impossible to analyze any data for this study.
Arm/Group Title Ibuprofen Placebo/Saline Solution
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Quality of Recovery Score (QoR-40).
Hide Description 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.
Time Frame 48h
Hide Outcome Measure Data
Hide Analysis Population Description
No data displayed because Outcome Measure has zero total participants analyzed.
Arm/Group Title Ibuprofen Placebo/Saline Solution
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Unfortunately, due to major flooding of our site during Hurricane Sandy, all data and samples for this study were lost. Therefore, no AE data is available.
 
Arm/Group Title Ibuprofen Placebo/Saline Solution
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Ibuprofen Placebo/Saline Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ibuprofen Placebo/Saline Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ibuprofen Placebo/Saline Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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
Layout table for Results Point of Contact information
Name/Title: Lisa Doan, MD
Organization: NYU School of Medicine
Phone: 212.263.5072
EMail: lisa.doan@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
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: December 22, 2017