Not Yet RecruitingPhase 4ACTRN12610000245099

Effects of Parecoxib on postoperative liver function in Patients Undergoing hepatectomy of hepatic carcinoma

Effects of Parecoxib, a selective cyclooxygenase-2 inhibitor,on liver function in Patients Undergoing hepatectomy of hepatic carcinoma: A Double-Blind, Randomized, Comparative Study


Sponsor

jinmin zhang

Enrollment

60 participants

Start Date

Apr 1, 2010

Study Type

Interventional

Conditions

Summary

Liver resection may require hepatic inflow occlusion to diminish intraoperative blood loss,thus may result in transient ischemia followed by reperfusion(I/R),which may initiate liver injury and lead to postoperative liver dysfunction. Nonsteroidal anti-inflammatory drugs (NSAIDs) may prevent or reduce hyperalgesia, inhibit inflammation, and reduce pain by reducing the synthesis of prostaglandins in response to tissue damage caused by surgery. There are some hepatic side effects reported by several spontaneous reports. While evidence from animal studies has shown that administration of COX-2 inhibitors minimize hepatic necrosis in chloroform induced liver injury. The aim of this study is to compare the effects of parecoxib, flurbiprofen and placebo in patients undergoing hepatectomy of hepatic carcinoma. Since Pringle’s maneuver are commonly applied by most of surgeons in our center which also cause an inevitable liver damage perioperatively, therefore providing us an ideal clinic model of hepatic I/R injury. The pain under mobilization registered via a visual analogue score. The injury of hepatocytes is evaluated by measuring plasma levels of alanine transaminase (ALT),aspartate aminotransferase(AST),interleukin 1 (IL-1), and tumor necrosis factor alpha (TNFa) levels. postoperative recovery is evaluated by hospital stay and complications. Liver resection may require hepatic inflow occlusion to diminish intraoperative blood loss,thus may result in transient ischemia followed by reperfusion(I/R),which may initiate liver injury and lead to postoperative liver dysfunction.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a pain medication called parecoxib can help protect the liver during and after surgery to remove liver tumors in patients aged 18 to 70 with liver cancer related to hepatitis B. The study combines general anesthesia with an epidural for pain management.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

1)Target controlled infusing(TCI) of propofol concentration of 3-6 ug/min, the individual patient’s dose is base on the clinical variables. 2)anaesthic administered from 30 minutes before commencement

1)Target controlled infusing(TCI) of propofol concentration of 3-6 ug/min, the individual patient’s dose is base on the clinical variables. 2)anaesthic administered from 30 minutes before commencement of surgery until completion of surgery. 3) the mode of administration: intravenous infusion .4) parecoxib 50mg intravenous infusion before cut skin and again after 6 hours . 5) Patient-controlled intravenous analgesia(PCIA) sufentanil will be administered for 2 days(background infusion is 2ml/h(sufentanil 2.4ug/h),bolus does is 2ml(sufentanil 2.4ug))


Locations(1)

shanghai, China

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ACTRN12610000245099