A Phase 4 interventional study of parecoxib in Gastrointestinal Cancer, sponsored by Jinling Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-11-10.
Sponsored by Jinling Hospital, China · Phase 4, Interventional, and Supportive care
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.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's planned enrollment of 164 is above the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Jinling Hospital, China is the lead sponsor of 126 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria：
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
Drug: parecoxib
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
Also known as: COX-2 selective inhibitors
Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery
Time frame: 5 days after operation
The consumption of total and incremental tramadol after surgery.
Time frame: 5 days after operation
The tolerated dose of enteral nutrition every day after surgery
Time frame: 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
Time frame: 5 days after operation
Rest energy metabolism was measured in perioperative period to evaluate the caloric and substrate needs of our patients
Time frame: 5 days after operation
The time of the first bowel movements and anal exhaust time after surgery
Time frame: 5 days after operation or more
Pain intensity at rest and during leg raising recorded daily after surgery using Visible Numeric Rating Scale
Time frame: 5 days after operation
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
Liver and renal function tests in perioperative period
Time frame: 5 days after operation
Self-rating anxiety scale and self-rating questionnaire for depression before surgery
Time frame: 1 day before surgery
This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jinling Hospital, China