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

NCT01930318 | Unknown Phase 4 DMC

• 1 other identifier: PTP-IR-EEN-1
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery

  5 days after operation

Secondary Outcomes (9)

• 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

Study Arms (4)

PCA,Placebo,Placebo

PLACEBO COMPARATOR

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

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

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

Drug: parecoxib

PCA,parecoxib,celecoxib

EXPERIMENTAL

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

Drug: parecoxib

Interventions

parecoxib DRUG

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

Also known as: COX-2 selective inhibitors

PCA,parecoxib,celecoxib; PCA,parecoxib,placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinling Hospital, China: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 200002, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 23328338 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

parecoxib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Wencheng Kong, MD

  Nanjing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wengcheng Kong, MD

CONTACT

15850722032; wenchengkong@gmail.com

Yousheng Li

CONTACT

8602580860137; liys@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Study Record Dates

• First Submitted: August 25, 2013
• First Posted: August 28, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 10, 2014

Record last verified: 2014-11

Locations

CN (1)