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Effect IV Ibuprofen and Inflammatory Responses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT01938040
First received: May 24, 2013
Last updated: October 28, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Gallbladder Disease Drug: ibuprofen Other: sugar water/placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):

Primary Outcome Measures:
  • Stress Response Inflammation Markers :Cortisol and C Reactive Protein (CRP) [ Time Frame: 2 hours following end of surgery ]
    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.


Secondary Outcome Measures:
  • Immune Response IL-6 [ Time Frame: 2 hours postoperatively in PACU ]
  • Quality of Recovery-40 [ Time Frame: preoperatively and -postoperative days 1 and 3 ]
    Quality of Recovery-40 has been used to assess postoperative recovery from anesthesia where higher score correlate with improved recovery and well being. The survey has 5 domains: comfort scale ranges 1-60 with higher value indicating greater comfort, emotions scale ranges 1-45 with higher value indicating best emotional state, physical independence scale ranges 1-25 with higher value indicating best independence, patient support scale ranges 1-35 with a higher score indicating greater support and pain scale 1-35 with higher number indicating greater relief from pain. Scoring is done for PART A on a scale of 1-5 (1=very poor=none of the time, worst score, 5=excellent=all of the time, best possible score).PART B on a scale of 1-5 (1=very poor or all the time worse score), 5=excellent or none of the time, best score) Perfect score=200.

  • Modified Fatigue Severity Scale [ Time Frame: preoperative-postoperative day 1 and day 3 ]
    This questionnaire contains 9 statements that rate severity of fatigue symptoms. Score 1 indicates strong disagreement with the statement and 7= strong agreement. i.e (I am easily fatigued).Total lowest possible score indicating no fatigue is 9. Total highest possible score is 63 which correlates to severe fatigue, interfering with all activities of daily living.

  • Immune Response:Serum Concentration of IL-10, [ Time Frame: 2 hours post arrival in PACU ]
    .drawn in PACU 2 hours following arrival and compared to preoperative and intraoperative values

  • Cognitive Recovery. [ Time Frame: preoperatively- 2 hours in PACU, Post op day #1, post op day#3 ]
    Digits span forward subject is asked to repeat a series of numbers with increasing number of digits forward. Digit span backward subject is asked to repeat a series of numbers backward with increasing number of digits. Correct response is worth 1 point. Maximum of 14 points for each sub score with a total of 28 points for total score

  • Geriatric Depression Scale [ Time Frame: Preoperatively, post operative day 1 and post op day3 ]
    15 questions. Score 1 point for each answer selected which indicates depression. Score of 0-5 is normal. A score >5 suggests depression.


Other Outcome Measures:
  • Cytokine Concentrations [ Time Frame: preoperative-intraoperative-postopoperative ]
    IFN y, IL-1B IL-2 were below the limit of detection and no assessments could be made. The lower limit for all cytokine detection was 3.2pg/mL


Enrollment: 60
Study Start Date: May 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ibuprofen
800mg administered IV in 100cc of normal saline over 5 minutes
Drug: ibuprofen
single preoperative dose prior to surgery
Other Name: caldolor
Placebo Comparator: Sugar water
100mL of normal saline to be administered over 5 minutes
Other: sugar water/placebo
single preoperative dose prior to surgery
Other Name: 100mL. intravenous sugar water administered over 5 minutes

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01938040

Locations
United States, New Jersey
University Hospital
Newark, New Jersey, United States, 07101
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
New York University Hospital
New York, New York, United States, 10016
MT. Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Alex Bekker, MD, PhD Rutgers/NJMS
  More Information

Publications:
Responsible Party: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT01938040     History of Changes
Other Study ID Numbers: 2012001793
Study First Received: May 24, 2013
Results First Received: September 23, 2015
Last Updated: October 28, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
laparoscopic cholecystectomy

Additional relevant MeSH terms:
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2017