Anesthetic Methods and Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01936545
Recruitment Status : Unknown
Verified July 2015 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 6, 2013
Last Update Posted : July 24, 2015
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Acute Lung Injury Drug: propofol during liver transplantation. Drug: Desflurane during liver transplantation. Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Impact of Different Anesthetic Methods on Ischemia Reperfusion Injury Following Liver Transplantation
Study Start Date : May 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change of cardiac output perioperatively [ Time Frame: one week ]
    Cardiac output(l/min) was measured by thermodilution method perioperatively.

Secondary Outcome Measures :
  1. lung injury score [ Time Frame: one week ]
    PaO2/FiO2(Arterial oxygen tension/fraction of inspired oxygen)

Other Outcome Measures:
  1. Reactive oxygen species [ Time Frame: one week ]
    Reactive oxygen species measured by chemiluminescence method

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Pre-existing pulmonary disease
  • coma

Information from the National Library of Medicine

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 identifier (NCT number): NCT01936545

Contact: Kuang Cheng Chan, M.D. 886-2-23123456 ext 62158

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
Principal Investigator: Kuang Cheng Chan, M.D. Department of Anesthesiology, NTUH, Taipei, Taiwan

Responsible Party: National Taiwan University Hospital Identifier: NCT01936545     History of Changes
Other Study ID Numbers: 201003116M
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015

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

Additional relevant MeSH terms:
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiration Disorders
Liver Extracts
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation