Effect IV Ibuprofen and Inflammatory Responses
Completed · Phase 4 · Has a placebo group
Conditions studied: Gallbladder Disease
In brief
This study is being done because the investigators wish to study ways to improve recovery after surgery. Injury, including surgical injury, causes inflammation. Inflammation is the body's attempt to protect itself and to start the healing process. Some surgical complications are related to the body's natural inflammatory response. Although mainly a healing response, inflammation can also have side effects which delay recovery. The investigators wish to determine the effect of a medication known as ibuprofen on recovery. You may know ibuprofen by the name Advil or Motrin. The medication will be given through the vein prior to the start of the surgery. Three blood samples will be taken, two while the patient is under anesthesia. The subject will be asked to complete several questionnaires.
Key facts
- Study ID
- NCT01938040
- Run by
- University of Medicine and Dentistry of New Jersey
- People needed
- 60
- Starts
- 2013-05-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2016-12-21
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- undergoing laparoscopic cholecystectomy under general anesthesia
- American Society of Anesthesiologists status of 1, 2 or 3 (as determined by the anesthesiologists)
- not pregnant of breast feeding
You may not qualify if…
- cognitively impaired
- using antipsychotic drugs
- chronic use of steroids or opioids
- subject has received COX inhibitors within 3 days if surgery
- subjects for whom opiates, benzodiazepines and COX inhibitors are contraindicated
- subjects with a history of bleeding disorders or peptic ulcer disease
Where it is running
- University Hospital — Newark, New Jersey, United States
- New York Methodist Hospital — Brooklyn, New York, United States
- New York University Hospital — New York, New York, United States
- MT. Sinai Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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