The Effects of the Anhepatic Phase Extended by Temporary Portocaval Shunt on Anesthetic Sensitivity and Cognitive Function

NCT02965131 | Completed DMC

• 1 other identifier: CR-16-159
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to investigate the effects of the anhepatic phase extended by temporary portocaval shunt on the sensitivity to desflurane administered at 0.6 age-adjusted minimum alveolar concentration and its associative postoperative cognitive function.

Conditions

Liver Cirrhoses

Outcome Measures

Primary Outcomes (1)

• Mini-Mental State Examination in the Korean Version of the Consortium to Establish a Registry for Alzheimer's Assessment Packet score

  Seven day after living donor liver transplantation

Secondary Outcomes (1)

• Bispectral index values

  During the preanhepatic, anhepatic, and neohepatic

Study Arms (2)

Non-temporary portocaval shunt

NO INTERVENTION

No temporary portacaval shunt is created. Full mobilization of the liver was followed by dissection of the hilar structure.

Temporary portocaval shunt

EXPERIMENTAL

Temporary portocaval shunt is created when inadvertent massive perihepatic bleeding or technical difficulties due to untypical patients' perihepatic anatomy are encountered during total hepatectomy. Hilar dissection preceded the dissection of the retrohepatic vena cava from the native liver. Its creating prolongs the duration of the anhepatic phase.

Procedure: Temporary portocaval shunt

Interventions

Temporary portocaval shunt PROCEDURE

The hepatic artery, bile duct, and portal vein are dissected and clamped. The retrohepatic vena cava is preserved with selective clamping of the hepatic veins during total hepatectomy. Then, temporary portocaval shunt is constructed by end-to-end anastomosis of the portal vein stump to the middle and left hepatic vein trunk or by end-to-side anastomosis of the stump to the infrahepatic vena cava depending on the remaining length of the vessels.

Temporary portocaval shunt

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver cirrhosis regardless of the concurrent presence of hepatocellular carcinoma

You may not qualify if:

• Alcoholic liver cirrhosis
• Acute liver failure
• A history of central nervous system disease (e.g., hepatic encephalopathy)
• Use of psychoactive drugs or alcohol within 6 months before the study
• Flapping tremor affecting handwriting performance necessary for assessing constructional praxis
• Difficulty in communicating with medical personnel
• Bispectral index values more than 60 under the predetermined end-tidal minimum alveolar concentration of desflurane during general anesthesia
• Reoperations
• Failure to wean from mechanical ventilation within 24 hours of arrival in the surgical intensive care unit
• Patient refusal

Sponsors & Collaborators

• Daegu Catholic University Medical Center: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 16, 2016
• Study Start: February 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: November 17, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share