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

Jinling Hospital, China

Status and phase: Unknown; Phase 4

Conditions: Gastrointestinal Cancer

Treatments: Drug: parecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT01930318

PTP-IR-EEN-1

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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164 participants in 4 patient groups, including a placebo group

PCA,Placebo,Placebo

Placebo Comparator group

Description:

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

Placebo Comparator group

Description:

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

PCA,parecoxib,placebo

Experimental group

Description:

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

Treatment:

Drug: parecoxib

PCA,parecoxib,celecoxib

Experimental group

Description:

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

Treatment:

Drug: parecoxib