Effect of COX-2 Selective Inhibitors on Postoperative Insulin Resistance After Gastrointestinal Laparoscopic Surgery
- Registration Number
- NCT01930318
- Lead Sponsor
- Jinling Hospital, China
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 164
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCA,parecoxib,placebo parecoxib 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 PCA,parecoxib,celecoxib parecoxib 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
- Primary Outcome Measures
Name Time Method Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery 5 days after operation
- Secondary Outcome Measures
Name Time Method Pain intensity at rest and during leg raising recorded daily after surgery using Visible Numeric Rating Scale 5 days after operation Incidence of adverse events throughout the treatment period including nausea, vomiting, headache, urinary retention, somnolence, flatulence, and pruritus 5 days after operation or more Liver and renal function tests in perioperative period 5 days after operation Self-rating anxiety scale and self-rating questionnaire for depression before surgery 1 day before surgery The consumption of total and incremental tramadol after surgery. 5 days after operation The tolerated dose of enteral nutrition every day after surgery 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 5 days after operation Rest energy metabolism was measured in perioperative period to evaluate the caloric and substrate needs of our patients 5 days after operation The time of the first bowel movements and anal exhaust time after surgery 5 days after operation or more
Trial Locations
- Locations (1)
Jinling Hospital
🇨🇳Nanjing, Jiangsu, China