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

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ClinicalTrials.gov Identifier: NCT01443572
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Kasai Operation Biliary Atresia Drug: desflurane anesthetics Drug: sevoflurane anesthetics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : September 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

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Arm Intervention/treatment
Experimental: desflurane group 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).

Active Comparator: sevoflurane group Drug: 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).




Primary Outcome Measures :
  1. Change in postoperative recovery [ Time Frame: after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days. ]
    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

  2. Change in hepatic function [ Time Frame: after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days ]
    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



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with biliary atresia undergoing Kasai operation

Exclusion Criteria:

  • patients with congenital anomalies at major organs

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443572


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01443572     History of Changes
Other Study ID Numbers: 4-2011-0436
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014

Keywords provided by Yonsei University:
Kasai operation under general anesthesia

Additional relevant MeSH terms:
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Biliary Atresia
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Abnormalities
Congenital Abnormalities
Anesthetics
Sevoflurane
Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General