The Comparison of Desflurane and Sevoflurane on Postoperative Recovery and Hepatic Function of Biliary Atresia Patients During Kasai Operation
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 16, 2011
CompletedFirst Posted
Study publicly available on registry
September 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJuly 22, 2014
July 1, 2014
2.8 years
September 16, 2011
July 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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
Study Arms (2)
desflurane group
EXPERIMENTALsevoflurane group
ACTIVE COMPARATORInterventions
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).
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).
Eligibility Criteria
You may qualify if:
- patients with biliary atresia undergoing Kasai operation
You may not qualify if:
- patients with congenital anomalies at major organs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, Seoul, 120-752, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2011
First Posted
September 29, 2011
Study Start
September 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
July 22, 2014
Record last verified: 2014-07