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

Primary Purpose

Gastrointestinal Cancer

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
parecoxib
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastrointestinal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jinling HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Arm Label

PCA,Placebo,Placebo

PCA,placebo,tramadol

PCA,parecoxib,placebo

PCA,parecoxib,celecoxib

Arm 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 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 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

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

Outcomes

Primary Outcome Measures

Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery

Secondary Outcome Measures

The consumption of total and incremental tramadol after surgery.
The tolerated dose of enteral nutrition every day after surgery
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
Rest energy metabolism was measured in perioperative period to evaluate the caloric and substrate needs of our patients
The time of the first bowel movements and anal exhaust time after surgery
Pain intensity at rest and during leg raising recorded daily after surgery using Visible Numeric Rating Scale
Incidence of adverse events throughout the treatment period including nausea, vomiting, headache, urinary retention, somnolence, flatulence, and pruritus
Liver and renal function tests in perioperative period
Self-rating anxiety scale and self-rating questionnaire for depression before surgery

Full Information

First Posted
August 25, 2013
Last Updated
November 7, 2014
Sponsor
Jinling Hospital, China
Collaborators
National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT01930318
Brief Title
Effect of COX-2 Selective Inhibitors on Postoperative Insulin Resistance After Gastrointestinal Laparoscopic Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
Collaborators
National Natural Science Foundation of China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCA,Placebo,Placebo
Arm Type
Placebo Comparator
Arm 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
Arm Title
PCA,placebo,tramadol
Arm Type
Placebo Comparator
Arm 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
Arm Title
PCA,parecoxib,placebo
Arm Type
Experimental
Arm 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
Arm Title
PCA,parecoxib,celecoxib
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
parecoxib
Other Intervention Name(s)
COX-2 selective inhibitors
Intervention Description
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
Primary Outcome Measure Information:
Title
Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery
Time Frame
5 days after operation
Secondary Outcome Measure Information:
Title
The consumption of total and incremental tramadol after surgery.
Time Frame
5 days after operation
Title
The tolerated dose of enteral nutrition every day after surgery
Time Frame
5 days after operation
Title
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
Title
Rest energy metabolism was measured in perioperative period to evaluate the caloric and substrate needs of our patients
Time Frame
5 days after operation
Title
The time of the first bowel movements and anal exhaust time after surgery
Time Frame
5 days after operation or more
Title
Pain intensity at rest and during leg raising recorded daily after surgery using Visible Numeric Rating Scale
Time Frame
5 days after operation
Title
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
Title
Liver and renal function tests in perioperative period
Time Frame
5 days after operation
Title
Self-rating anxiety scale and self-rating questionnaire for depression before surgery
Time Frame
1 day before surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wengcheng Kong, MD
Phone
15850722032
Email
wenchengkong@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yousheng Li
Phone
8602580860137
Email
liys@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wencheng Kong, MD
Organizational Affiliation
Nanjing University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
200002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wencheng Kong, MD
Phone
15850722032
Email
wenchengkong@gmail.com
First Name & Middle Initial & Last Name & Degree
Yousheng Li, MD
Email
liys@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Wencheng Kong, MD
First Name & Middle Initial & Last Name & Degree
Danhua Yao, MD
First Name & Middle Initial & Last Name & Degree
lele Ren, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23328338
Citation
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.
Results Reference
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Effect of COX-2 Selective Inhibitors on Postoperative Insulin Resistance After Gastrointestinal Laparoscopic Surgery

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