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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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000245099
Acronym
None
Enrollment
60
Registered
2010-03-24
Start date
2010-04-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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(suf

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))

Sponsors

jinmin zhang
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1.elective liver resection 2. American Society of Anesthesiologists (ASA) physical status 2-3 patients 3.Primary liver cancer patients who had history of hepatitis B related cirrhosis 4.undergoing combine general and epidural anesthesia

Exclusion criteria

1contradictions of epidural puncture including coagulate disorder (prothrombin time (PT) longer than 15 sec or/and blood platelets count less than 10,000 ). 2.tumor size too small or too large(longitude of tumor was beyond 3-8 cm ) or estimated blood loss was large than 1000 cc. 3.Individuals in whom the regional block failed and surgery was performed under general anesthesia alone were also withdrawn from the study.. 4.Patients with a known allergy to NSAIDs 5.Patients who had received chemotherapy and radiation prior to surgery 6.patients who with a history of peptic ulceration, or renal, cardiac, endocrine 7. Patients who had received Non steroidal anti-inflammatory drugs (NSAIDs) within 14 days before enrollment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026