The Comparison of Desflurane and Sevoflurane on Postoperative Recovery and Hepatic Function of Biliary Atresia Patients During Kasai Operation

Biliary Atresia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443572
• Other study ID #: 4-2011-0436
• Status: Completed
• Phase: N/A
• First received: September 16, 2011
• Last updated: July 20, 2014
• Start date: September 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

Biliary atresia (BA) is a perinatal disease of unclear etiology, characterized by inflammation and obliteration of intrahepatic and extrahepatic bile ducts, leading to cholestasis and cirrhosis. Kasai operation remains as the first line operative treatment in BA. In the previous studies, inhalation anesthetics might induce liver damage. The choice of inhalation anesthetic that minimally affects hepatic function is important. Therefore, the purpose of this study is to compare the postoperative recovery and hepatic function between desflurane and sevoflurane, two most frequently used inhalational anesthetics in patients undergoing Kasai operation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• patients with biliary atresia undergoing Kasai operation

Exclusion Criteria:

• patients with congenital anomalies at major organs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Atresia
• Kasai Operation

Intervention

Drug:
• desflurane anesthetics
40 patients are randomly allocated into two groups : desflurane group (n=20) and sevoflurane group (n=20). And anesthesia is maintained with desflurane (desflurane group) or sevoflurane (sevoflurane group).
• sevoflurane anesthetics
40 patients are randomly allocated into two groups : desflurane group (n=20) and sevoflurane group (n=20). And anesthesia is maintained with desflurane (desflurane group) or sevoflurane (sevoflurane group).

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postoperative recovery	Complete blood count(CBC), prothrombin time(PT), activated partial thromboplastin time(APTT), aspartate aminotransferase(AST), alanine aminotransferase(ALT), alkaline phosphatase(ALP), albumin, total bilirubin, direct bilirubin, gamma-GTP, BUN, creatinine(Cr), electrolyte	after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days.	No
Primary	Change in hepatic function	Complete blood count(CBC), prothrombin time(PT), activated partial thromboplastin time(APTT), aspartate aminotransferase(AST), alanine aminotransferase(ALT), alkaline phosphatase(ALP), albumin, total bilirubin, direct bilirubin, gamma-GTP, BUN, creatinine(Cr), electrolyte	after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days	No