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Completed

NCT Number: NCT02471209

Biliary Atresia, Hepatic Buffer Response and Sevoflurane

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

general anesthesia with 2% followed by 3% sevoflurane

Other names: general anesthesia

Primary outcomes

  1. portal blood flow

    Time frame: 10 minutes

  2. hepatic arterial blood flow

    Time frame: 10 minutes

  3. hepatic blood flow

    Time frame: 10 minutes

Secondary outcomes

  1. blood pressure

    Time frame: 5 minutes

    noninvasive blood pressure

  2. renal blood flow

    Time frame: 10 minutes

  3. femoral vein blood flow

    Time frame: 10 minutes

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 15, 2015
Registry last updated
Jun 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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