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

Phase 4UnknownNCT01930318

Jinling Hospital, China164 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

164

Conditions

Gastrointestinal Cancer

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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