Clinical trial NCT01930318: Effect of COX-2 Selective Inhibitors on Postoperative Insulin Resistance After Gastrointestinal Laparoscopic Surgery
Official title: 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: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastrointestinal Cancer
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2013-08-28
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery
timeFrame: 5 days after operation
Secondary outcomes:
measure: The consumption of total and incremental tramadol after surgery.
timeFrame: 5 days after operation
measure: The tolerated dose of enteral nutrition every day after surgery
timeFrame: 5 days after operation
measure: 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
timeFrame: 5 days after operation
measure: Rest energy metabolism was measured in perioperative period to evaluate the caloric and substrate needs of our patients
timeFrame: 5 days after operation
measure: The time of the first bowel movements and anal exhaust time after surgery
timeFrame: 5 days after operation or more
measure: Pain intensity at rest and during leg raising recorded daily after surgery using Visible Numeric Rating Scale
timeFrame: 5 days after operation
measure: Incidence of adverse events throughout the treatment period including nausea, vomiting, headache, urinary retention, somnolence, flatulence, and pruritus
timeFrame: 5 days after operation or more
measure: Liver and renal function tests in perioperative period
timeFrame: 5 days after operation
measure: Self-rating anxiety scale and self-rating questionnaire for depression before surgery
timeFrame: 1 day before surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing University
name: Wencheng Kong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.