Effect of COX-2 Selective Inhibitors on Postoperative Insulin Resistance After Gastrointestinal Laparoscopic Surgery

Overview

It is well established that the resistance to the effects of insulin on glucose metabolism develops with a lot of stress hormone release after surgical trauma. This condition is known as insulin resistance (IR) characterized by hyperglycemia, hyperinsulinemia and lactic acidosis. Surgical IR not only affect glucose metabolism but also influence protein synthesis, then further exacerbate the depletion of the carbohydrate, fat and protein. Postoperative pain is a challenging task for patients and surgeons, and it is part of the stress response to trauma and surgery, while the fear of pain can exacerbate the stress response. The main aim of this study was to invest whether effective postoperative analgesia can reduce the stress response and insulin resistance.

Full Title of Study: “Effect of COX-2 Selective Inhibitors on Postoperative Insulin Resistance, Tramadol PCA and Early Postoperative Enteral Nutrition in Patients After Gastrointestinal Laparoscopic Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: August 2015

Interventions

  • Drug: parecoxib
    • 4 groups: PCA,Placebo,Placebo-PCA for 2 days after operation, i.v placebo in 2 days after surgery and oral placebo in the day 3 to day 5 after surgery; PCA,placebo,tramadol-PCA for 2 days after operation, i.v placebo in 2 days after surgery, and oral tramadol(0.1g t.i.d.) in the day 3 to day 5 after surgery;PCA,parecoxib,placebo-PCA for 2 days after operation, i.v parecoxib(40mg b.i.d.) in 2 days after surgery,and oral placebo in the day 3 to day 5 after surgery;PCA,parecoxib,celecoxib-PCA for 2 days after operation,i.v parecoxib(40mg b.i.d.) in 2 days after surgery and oral celecoxib(0.2g b.i.d.) in the day 3 to day 5 after surgery

Arms, Groups and Cohorts

  • Placebo Comparator: PCA,Placebo,Placebo
    • PCA for 2 days after operation, i.v placebo in 2 days after surgery and oral placebo in the day 3 to day 5 after surgery
  • Placebo Comparator: PCA,placebo,tramadol
    • PCA for 2 days after operation, i.v placebo in 2 days after surgery, and oral tramadol in the day 3 to day 5 after surgery
  • Experimental: PCA,parecoxib,placebo
    • PCA for 2 days after operation, i.v parecoxib in 2 days after surgery,and oral placebo in the day 3 to day 5 after surgery
  • Experimental: PCA,parecoxib,celecoxib
    • PCA for 2 days after operation,i.v parecoxib in 2 days after surgery and oral celecoxib in the day 3 to day 5 after surgery

Clinical Trial Outcome Measures

Primary Measures

  • Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery
    • Time Frame: 5 days after operation

Secondary Measures

  • The consumption of total and incremental tramadol after surgery.
    • Time Frame: 5 days after operation
  • The tolerated dose of enteral nutrition every day after surgery
    • Time Frame: 5 days after operation
  • Postoperative inflammatory factors (IL-4, IL-6 and TNF-α) and levels of stress hormone (glucocorticoids and catecholamines) in perioperative period of gastrointestinal laparoscopic surgery
    • Time Frame: 5 days after operation
  • Rest energy metabolism was measured in perioperative period to evaluate the caloric and substrate needs of our patients
    • Time Frame: 5 days after operation
  • The time of the first bowel movements and anal exhaust time after surgery
    • Time Frame: 5 days after operation or more
  • Pain intensity at rest and during leg raising recorded daily after surgery using Visible Numeric Rating Scale
    • Time Frame: 5 days after operation
  • Incidence of adverse events throughout the treatment period including nausea, vomiting, headache, urinary retention, somnolence, flatulence, and pruritus
    • Time Frame: 5 days after operation or more
  • Liver and renal function tests in perioperative period
    • Time Frame: 5 days after operation
  • Self-rating anxiety scale and self-rating questionnaire for depression before surgery
    • Time Frame: 1 day before surgery

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with gastrointestinal cancer scheduled for gastrointestinal laparoscopic surgery – Patients between the ages of 18 and 70 yr – ASA physical status I-II – Requirements of informed consent and assent of participant, parent or legal guardian as applicable – Consciousness and ability to cooperate Exclusion criteria: – History of alcohol, analgesic, or narcotic abuse – Used analgesics, neuroleptics, antipsychotic agents, or corticosteroids within 6 hours of surgery – A clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease – Female with positive pregnancy – Allergy to conventional NSAIDs

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jinling Hospital, China
  • Collaborator
    • National Natural Science Foundation of China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kong Wencheng, Senior Resident – Jinling Hospital, China
  • Overall Official(s)
    • Wencheng Kong, MD, Principal Investigator, Nanjing University
  • Overall Contact(s)
    • Wengcheng Kong, MD, 15850722032, wenchengkong@gmail.com

References

Xu Z, Li Y, Wang J, Li J. Effect of postoperative analgesia on energy metabolism and role of cyclooxygenase-2 inhibitors for postoperative pain management after abdominal surgery in adults. Clin J Pain. 2013 Jul;29(7):570-6. doi: 10.1097/AJP.0b013e318270f97b.

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