Biliary Atresia, Hepatic Buffer Response and Sevoflurane

NCT ID: NCT02471209

Last Updated: 2015-06-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-02-28

Brief Summary

To evaluate the effects of sevoflurane on hepatic blood flow (HBF) and hepatic arterial buffer response (HABR) in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. portal vein blood flow (PBF), hepatic arterial blood flow (HABF) and hepatic blood flow (HBF) were measured by Doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.

Detailed Description

Children suffering from hepatobiliary disease also have an hepatic arterial buffer response (HABR) with reduced portal vein blood flow (PBF) and compensatory increases in hepatic arterial blood flow (HABF) which can help maintain hepatic blood flow (HBF). For infants with obstructive hepatobiliary disease, reduced HBF may affect drug metabolism and increase the risk of respiratory depression during analgesia, which can be life-threatening.

To evaluate the effects of sevoflurane on HBF and HABR in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. PBF, HABF and HBF were measured by Doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.

Conditions

Biliary Atresia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Biliary Atresia Infants

Twenty-five infants diagnosed with Biliary Atresia and undergoing surgery were included in the study (age range 1-3 months). Inclusion criteria were persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly; increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (TBil) dominated by increased direct bilirubin (DBil) (\>60%); elevated liver enzymes; ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis; with radionuclide imaging confirmation of obstructed biliary excretion. Infants were excluded if they had concomitant cardiovascular or abdominal organ malformations.

Sevoflurane

Intervention Type: DRUG

general anesthesia with 2% followed by 3% sevoflurane

Interventions

Sevoflurane

general anesthesia with 2% followed by 3% sevoflurane

Intervention Type: DRUG

Other Intervention Names

general anesthesia

Eligibility Criteria

Inclusion Criteria

• persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly;
• increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (TBil) dominated by increased direct bilirubin (DBil) (>60%);
• elevated liver enzymes;
• ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis;
• with radionuclide imaging confirmation of obstructed biliary excretion

Exclusion Criteria

• concomitant cardiovascular or abdominal organ malformations

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

mzk-0003-2011

Identifier Type: -

Identifier Source: org_study_id