Clinical Trial: Effect IV Ibuprofen and Inflammatory Responses

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

This is a randomized, double-blind, placebo-controlled, two-arm parallel, multi-center study.

Thirty subjects (15 in each arm) will be enrolled. Subjects, over the age of 18, undergoing laparoscopic cholecystectomy under general anesthesia will be screened for eligibility to participate in the study. Subjects will be screened, recruited, and randomized during the preadmission visit or the day of surgery. 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. Both men and women will be recruited, and there is no limitation as to racial and ethnic origin.

Participation in the study will not alter the patient's anesthetic management. Routine anesthesia monitors used during general anesthesia will be used. Patients will receive either 800mg IV ibuprofen or placebo pre-operatively. After pre-oxygenation, general anesthesia will be induced with lidocaine (1 mg/kg), propofol (1-2 mg/kg), and fentanyl (up to 5 mcg/kg). Tracheal intubation will be facilitated with rocuronium (0.6 mg/kg). Anesthesia will be maintained with air/oxygen (60%/40%), sevoflurane, and fentanyl. The anesthesiologist will be allowed to administer additional doses of fentanyl at his/her discretion. All patients will receive ondansetron 4 mg prior to the end of operation. Patients will be awakened and extubated in the OR and will be transferred to the Post Anesthesia Care Unit (PACU) after following simple commands. All patients will also be able to receive rescue doses of opioids as indicated by a Numeric Pain Rating Scale score >2 or upon request.

ii. Sample Size Justification: The proposed study is a pilot trial designed to explore the relationship between inflammatory markers and the quality of recovery. To our knowledge t
Sponsor: University of Medicine and Dentistry of New Jersey

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

Original Primary Outcome: inflammatory markers [ Time Frame: 2 hours following end of surgery ]

Current Secondary Outcome:

• 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.

Original Secondary Outcome: Quality of recovery [ Time Frame: Change from baseline at 48 hours post operatively ]

Dates:
Date Received: May 24, 2013
Date Started: May 2013
Date Completion:
Last Updated: October 28, 2016
Last Verified: October 2016