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

Gastrointestinal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01930318
• Other study ID #: PTP-IR-EEN-1
• Status: Recruiting
• Phase: Phase 4
• First received: August 25, 2013
• Last updated: November 7, 2014
• Start date: August 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2014
• Source: Jinling Hospital, China
• Contact: Wengcheng Kong, MD
• Phone: 15850722032
• Email: wenchengkong[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Insulin Resistance

Intervention

Drug:
• parecoxib
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

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jinling Hospital, China	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery		5 days after operation	Yes
Secondary	The consumption of total and incremental tramadol after surgery.		5 days after operation	Yes
Secondary	The tolerated dose of enteral nutrition every day after surgery		5 days after operation	No
Secondary	Postoperative inflammatory factors (IL-4, IL-6 and TNF-a) and levels of stress hormone (glucocorticoids and catecholamines) in perioperative period of gastrointestinal laparoscopic surgery		5 days after operation	Yes
Secondary	Rest energy metabolism was measured in perioperative period to evaluate the caloric and substrate needs of our patients		5 days after operation	Yes
Secondary	The time of the first bowel movements and anal exhaust time after surgery		5 days after operation or more	Yes
Secondary	Pain intensity at rest and during leg raising recorded daily after surgery using Visible Numeric Rating Scale		5 days after operation	Yes
Secondary	Incidence of adverse events throughout the treatment period including nausea, vomiting, headache, urinary retention, somnolence, flatulence, and pruritus		5 days after operation or more	No
Secondary	Liver and renal function tests in perioperative period		5 days after operation	Yes
Secondary	Self-rating anxiety scale and self-rating questionnaire for depression before surgery		1 day before surgery	Yes