Phase 4
Completed N=55
Effect IV Ibuprofen and Inflammatory Responses
Gallbladder Disease
Source: ClinicalTrials.gov NCT01938040 ↗
Enrolled (actual)
55
Serious AEs
1.8%
Results posted
Dec 2016
Primary outcomePrimary: Stress Response Inflammation Markers :Cortisol and C Reactive Protein (CRP) — 173.6; 289.5; 17; 17 pg/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stress Response Inflammation Markers :Cortisol and C Reactive Protein (CRP) |
173.6; 289.5; 17; 17 | — |
| SECONDARY Immune Response IL-6 |
8.3; 7.7; 1.4; 1.2; 1.9; 1.1 | — |
| SECONDARY Quality of Recovery-40 |
56.5; 56.8; 42.9; 43; 24.8; 24.6 | — |
| SECONDARY Modified Fatigue Severity Scale |
16.7; 16.5; 18.6; 26.9; 15.5; 25 | — |
| SECONDARY Immune Response:Serum Concentration of IL-10, |
8.3; 21.8; 2.1; 1.3; 3.3; 2.5 | 0.001 sig |
| SECONDARY Cognitive Recovery. |
8.4; 8.9; 6.9; 7.08; 7.7; 7.7 | — |
| SECONDARY Geriatric Depression Scale |
0.5; 0.7; 0.7; 0.9; 0.4; 0.4 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01938040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.