Anesthetic Methods and Liver Transplantation

This study is currently recruiting participants.
Verified September 2013 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01936545
First received: August 27, 2013
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

Postoperative pulmonary complications are not uncommon after liver transplantation. They can not only prolong the stay in intensive care unit and in hospital but also increase the morbidity and mortality rate. The underlying mechanisms are multifactorial, however, oxidative stress following hepatic ischemia reperfusion and the ensuing pulmonary leukocyte infiltration play an important part in the pulmonary complications. Various drugs and methods such as ischemic preconditioning have been used to lessen the production of oxidative free radicals following hepatic ischemia reperfusion. The choice of different anesthetic agents could aslo change the degree of production of oxygen species and antioxidant capacity during the operation.

Volatile and intravenous anesthetic agents can decrease oxidative injuries through different mechanisms, however, which is better in preventing the pulmonary leukocyte infiltration is still unknown.

We attempt the compare the oxidative stress and cytokine level in liver transplant recipients under desflurane or propofol anesthesia to evaluate which kind of anesthetic agent is better in this kind of surgery.


Condition Intervention
Acute Lung Injury
Drug: propofol during liver transplantation.
Drug: Desflurane during liver transplantation.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Impact of Different Anesthetic Methods on Ischemia Reperfusion Injury Following Liver Transplantation

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Change of cardiac output perioperatively [ Time Frame: one week ] [ Designated as safety issue: No ]
    Cardiac output(l/min) was measured by thermodilution method perioperatively.


Secondary Outcome Measures:
  • lung injury score [ Time Frame: one week ] [ Designated as safety issue: No ]
    PaO2/FiO2(Arterial oxygen tension/fraction of inspired oxygen)


Other Outcome Measures:
  • Reactive oxygen species [ Time Frame: one week ] [ Designated as safety issue: No ]
    Reactive oxygen species measured by chemiluminescence method


Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: propofol
The anesthesia was maintained with propofol during liver transplantation.
Drug: propofol during liver transplantation.
The anesthesia was maintained with propofol during liver transplantation.
Other Name: propofol
Active Comparator: Desflurane
The anesthesia was maintained with desflurane during liver transplantation.
Drug: Desflurane during liver transplantation.
The anesthesia was maintained with desflurane during liver transplantation.
Other Name: Desflurane

Detailed Description:

The occurrence of postoperative pulmonary complications after hepatic reperfusion, such as in patients undergoing liver transplantation, is a major concern in the intensive care unit. Not only neutrophil infiltration, but also oxidative injuries, have been demonstrated after intra-operative hepatic ischemia/reperfusion (I/R) management. Previous studies have shown that reactive oxygen species (ROS) paly a major role in the ensuing damage, although I/R-induced remote organ injury is a complex and multifactorial process. Methods to reduce ROS generation, such as ischemic preconditioning, attenuate both liver and lung damage after hepatic I/R. Considering the intra-operative ROS production occurs after hepatic reperfusion , the choice of anesthetics may alter the magnitude of ROS production and the antioxidant capacity.

Volatile and non-volatile anesthetics can exert their antioxidant capacity through different mechanisms. Propofol (2,6-diisopropylphenol) has been reported to provide antioxidant capacity by scavenging free radicals. However, volatile anesthetics such as isoflurane, desflurane or sevoflurane can reduce the oxidative damage through anesthetic preconditioning. Several animal studies demonstrate that volatile anesthetics offer more protection against ischemia-reperfusion injury than intravenous anesthetics. On the contrary, intravenous anesthetics may be more protective against sepsis-induced hepatic injury than volatile anesthetics. However, there are few investigations concerning the effects of different anesthetics on remote pulmonary injuries in clinical settings.

In this study, propofol and desflurane will be used for the maintenance of anesthesia during liver transplantation. The heart function, respiratory function, liver function, kidney function, the oxidative injuries and inflammatory mediators will be compared between the two groups.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • End stage liver disease scheduled for liver transplantation in National Taiwan University Hospital

Exclusion Criteria:

  • Pre-existing pulmonary disease
  • coma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01936545

Contacts
Contact: Kuang Cheng Chan, M.D. 886-2-23123456 ext 62158 jkjchan@gmail.com

Locations
Taiwan
Department of Anesthesiology, NTUH, Taipei, Taiwan Recruiting
Taipei, Taiwan
Contact: Kuang Cheng Chan, M.D.         
Principal Investigator: Kuang Cheng Chan, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Kuang Cheng Chan, M.D. Department of Anesthesiology, NTUH, Taipei, Taiwan
  More Information

Publications:
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01936545     History of Changes
Other Study ID Numbers: 201003116M
Study First Received: August 27, 2013
Last Updated: September 3, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Liver transplantation, reactive oxygen species, antioxidant

Additional relevant MeSH terms:
Reperfusion Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries
Anesthetics
Propofol
Desflurane
Liver Extracts
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hematinics
Hematologic Agents
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on April 16, 2014