Trial Outcomes & Findings for Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia. (NCT NCT01377441)
NCT ID: NCT01377441
Last Updated: 2017-12-22
Results Overview
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.
TERMINATED
PHASE4
6 participants
48h
2017-12-22
Participant Flow
Patients were recruited from the perioperative area.
Participant milestones
| Measure |
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.
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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.
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Overall Study
STARTED
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia.
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 48hPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48hPopulation: No data displayed because Outcome Measure has zero total participants analyzed.
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.
Outcome measures
Outcome data not reported
Adverse Events
Ibuprofen
Placebo/Saline Solution
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place