Gastrointestinal Cancer
Conditions
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.
Interventions
DRUGparecoxib
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
Sponsors
National Natural Science Foundation of China
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery | 5 days after operation |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity at rest and during leg raising recorded daily after surgery using Visible Numeric Rating Scale | 5 days after operation |
| Self-rating anxiety scale and self-rating questionnaire for depression before surgery | 1 day before surgery |
| Incidence of adverse events throughout the treatment period including nausea, vomiting, headache, urinary retention, somnolence, flatulence, and pruritus | 5 days after operation or more |
| The consumption of total and incremental tramadol after surgery. | 5 days after operation |
| Liver and renal function tests in perioperative period | 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 |
| The tolerated dose of enteral nutrition every day after surgery | 5 days after operation |
Countries
China
Contacts
Primary ContactWengcheng Kong, MD
Backup ContactYousheng Li
Outcome results
None listed