Effect IV Ibuprofen and Inflammatory Responses
Randomized, Double Blind, Pilot Study on the Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia: Correlation With Clinical Outcomes
1 other identifier
interventional
60
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2013
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 24, 2013
CompletedFirst Posted
Study publicly available on registry
September 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
December 21, 2016
CompletedDecember 21, 2016
October 1, 2016
1.3 years
May 24, 2013
September 23, 2015
October 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stress Response Inflammation Markers :Cortisol and C Reactive Protein (CRP)
Serum concentration of cortisol, CRP, drawn in Post Anesthesia Care unit at 2 hours following surgery were compared with those same levels drawn preoperatively and intraoperatively.
2 hours following end of surgery
Secondary Outcomes (6)
Immune Response IL-6
2 hours postoperatively in PACU
Quality of Recovery-40
preoperatively and -postoperative days 1 and 3
Modified Fatigue Severity Scale
preoperative-postoperative day 1 and day 3
Immune Response:Serum Concentration of IL-10,
2 hours post arrival in PACU
Cognitive Recovery.
preoperatively- 2 hours in PACU, Post op day #1, post op day#3
- +1 more secondary outcomes
Other Outcomes (1)
Cytokine Concentrations
preoperative-intraoperative-postopoperative
Study Arms (2)
Ibuprofen
ACTIVE COMPARATOR800mg administered IV in 100cc of normal saline over 5 minutes
Sugar water
PLACEBO COMPARATOR100mL of normal saline to be administered over 5 minutes
Interventions
single preoperative dose prior to surgery
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University Hospital
Newark, New Jersey, 07101, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
New York University Hospital
New York, New York, 10016, United States
MT. Sinai Medical Center
New York, New York, 10029, United States
Related Publications (1)
Le V, Kurnutala L, SchianodiCola J, Ahmed K, Yarmush J, Daniel Eloy J, Shapiro M, Haile M, Bekker A. Premedication with Intravenous Ibuprofen Improves Recovery Characteristics and Stress Response in Adults Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial. Pain Med. 2016 Jun;17(6):1163-1173. doi: 10.1093/pm/pnv113. Epub 2016 Feb 18.
PMID: 26893119BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alex Bekker, MD, PhD
- Organization
- Rutgers/State University of New Jersey (NJMS)
Study Officials
- PRINCIPAL INVESTIGATOR
Alex Bekker, MD, PhD
Rutgers/NJMS
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2013
First Posted
September 10, 2013
Study Start
May 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
December 21, 2016
Results First Posted
December 21, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share