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

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ClinicalTrials.gov Identifier: NCT01930318
Recruitment Status : Unknown
Verified November 2014 by Kong Wencheng, Jinling Hospital, China.
Recruitment status was:  Recruiting
First Posted : August 28, 2013
Last Update Posted : November 10, 2014
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Kong Wencheng, Jinling Hospital, China

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.


Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Drug: parecoxib Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : August 2013
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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
Placebo Comparator: PCA,placebo,tramadol
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
Experimental: PCA,parecoxib,placebo
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
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
Other Name: COX-2 selective inhibitors

Experimental: PCA,parecoxib,celecoxib
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
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
Other Name: COX-2 selective inhibitors




Primary Outcome Measures :
  1. Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery [ Time Frame: 5 days after operation ]

Secondary Outcome Measures :
  1. The consumption of total and incremental tramadol after surgery. [ Time Frame: 5 days after operation ]
  2. The tolerated dose of enteral nutrition every day after surgery [ Time Frame: 5 days after operation ]
  3. 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 [ Time Frame: 5 days after operation ]
  4. Rest energy metabolism was measured in perioperative period to evaluate the caloric and substrate needs of our patients [ Time Frame: 5 days after operation ]
  5. The time of the first bowel movements and anal exhaust time after surgery [ Time Frame: 5 days after operation or more ]
  6. Pain intensity at rest and during leg raising recorded daily after surgery using Visible Numeric Rating Scale [ Time Frame: 5 days after operation ]
  7. Incidence of adverse events throughout the treatment period including nausea, vomiting, headache, urinary retention, somnolence, flatulence, and pruritus [ Time Frame: 5 days after operation or more ]
  8. Liver and renal function tests in perioperative period [ Time Frame: 5 days after operation ]
  9. Self-rating anxiety scale and self-rating questionnaire for depression before surgery [ Time Frame: 1 day before surgery ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930318


Contacts
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Contact: Wengcheng Kong, MD 15850722032 wenchengkong@gmail.com
Contact: Yousheng Li 8602580860137 liys@medmail.com.cn

Locations
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China, Jiangsu
Jinling Hospital Recruiting
Nanjing, Jiangsu, China, 200002
Contact: Wencheng Kong, MD    15850722032    wenchengkong@gmail.com   
Contact: Yousheng Li, MD       liys@medmail.com.cn   
Principal Investigator: Wencheng Kong, MD         
Sub-Investigator: Danhua Yao, MD         
Sub-Investigator: lele Ren, PhD         
Sponsors and Collaborators
Jinling Hospital, China
National Natural Science Foundation of China
Investigators
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Principal Investigator: Wencheng Kong, MD Nanjing University

Publications:
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Responsible Party: Kong Wencheng, Senior Resident, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01930318     History of Changes
Other Study ID Numbers: PTP-IR-EEN-1
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
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Insulin Resistance
Gastrointestinal Neoplasms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Celecoxib
Parecoxib
Tramadol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants