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

Primary Purpose

Kasai Operation, Biliary Atresia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
desflurane anesthetics
sevoflurane anesthetics
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kasai Operation focused on measuring Kasai operation under general anesthesia

Eligibility Criteria

undefined - 1 Year (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with biliary atresia undergoing Kasai operation

Exclusion Criteria:

  • patients with congenital anomalies at major organs

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

desflurane group

sevoflurane group

Arm Description

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
September 16, 2011
Last Updated
July 20, 2014
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01443572
Brief Title
The Comparison of Desflurane and Sevoflurane on Postoperative Recovery and Hepatic Function of Biliary Atresia Patients During Kasai Operation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kasai Operation, Biliary Atresia
Keywords
Kasai operation under general anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
desflurane group
Arm Type
Experimental
Arm Title
sevoflurane group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
desflurane anesthetics
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
sevoflurane anesthetics
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in postoperative recovery
Description
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
Time Frame
after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days.
Title
Change in hepatic function
Description
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
Time Frame
after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with biliary atresia undergoing Kasai operation Exclusion Criteria: patients with congenital anomalies at major organs
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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