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Trial registered on ANZCTR


Registration number
ACTRN12612000305820
Ethics application status
Approved
Date submitted
13/03/2012
Date registered
16/03/2012
Date last updated
16/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Target-controlled propofol infusion anaesthesia provides better immediate anaesthesia outcome than desflurane anaesthesia in liver transplantation patients
Scientific title
This retrospective comparative study was compared the outcomes in the perioperative management and postoperative recovery which performed in deceased or living donor liver transplantation recipients who received total intravenous anesthesia with propofol versus desflurane anesthesia.
Secondary ID [1] 280109 0
Nil
Universal Trial Number (UTN)
U1111-1129-0228
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Associated patient outcome in deceased or living donor liver transplantation recipients who received TIVA with propofol anesthesia versus desflurane anesthesia 286037 0
Condition category
Condition code
Anaesthesiology 286226 286226 0 0
Anaesthetics
Oral and Gastrointestinal 286267 286267 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The retrospective comparative study compared the outcomes in the perioperative management and postoperative recovery in deceased or living donor liver transplantation recipients who received total intravenous anesthesia with propofol or desflurane anesthesia at Tri-Service General Hospital.
Medical records of all the liver recipients were collected and reviewed from September 2007 to August 2010.
Intervention code [1] 284450 0
Not applicable
Comparator / control treatment
Electronic/paper medical records of all the liver recipients who underwent primary deceased or living-donor LT were collected and reviewed from September 2007 to August 2010.
Control group
Active

Outcomes
Primary outcome [1] 286705 0
Norepinephrine use during reperfusion as assessed by medical records.
After reperfusion, bolus of norepinephrine was used to keep mean arterial pressure above 60 mmHg or within 30% of pre-reperfusion systolic arterial pressure.
Timepoint [1] 286705 0
During reperfusion period (via paper medical records)
Secondary outcome [1] 296497 0
Postoperative recovery outcomes: awake time
Timepoint [1] 296497 0
at any time during the study period (via electronic/paper medical records)
Secondary outcome [2] 296553 0
Postoperative recovery outcomes: extubation time
Timepoint [2] 296553 0
at any time during the study period (via electronic/paper medical records)
Secondary outcome [3] 296554 0
Alanine aminotransferase (ALT) concentration
Timepoint [3] 296554 0
24 hours after transplantation
Secondary outcome [4] 296555 0
Postoperative recovery outcomes: intensive care unit (ICU) stay
Timepoint [4] 296555 0
at least 60 days after surgery (via electronic/paper medical records)
Secondary outcome [5] 296556 0
Postoperative recovery outcomes: days in hospital
Timepoint [5] 296556 0
at least 60 days after surgery (via electronic/paper medical records)

Eligibility
Key inclusion criteria
All the liver recipients who received total intravenous anesthesia with propofol or desflurane anesthesia operated at Tri-Service General Hospital from September 2007 to August 2010.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded if they met any of the following criteria: presence of encephalopathy, requirements for pretransplant endotracheal intubation/mechanical ventilation, or use of vasopressors before transplantation.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4193 0
Taiwan, Province Of China
State/province [1] 4193 0

Funding & Sponsors
Funding source category [1] 284880 0
Self funded/Unfunded
Name [1] 284880 0
Chueng-He Lu
Address [1] 284880 0
Department of Anesthesiology
Tri-Service General Hospital
#325, Section 2, Chenggung Road, Neihu 114, Taipei
Country [1] 284880 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Chueng-He Lu
Address
Department of Anesthesiology
Tri-Service General Hospital
#325, Section 2, Chenggung Road, Neihu 114, Taipei
Country
Taiwan, Province Of China
Secondary sponsor category [1] 283759 0
None
Name [1] 283759 0
Address [1] 283759 0
Country [1] 283759 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286872 0
Institutional Review Board of Tri-Service General Hospital
Ethics committee address [1] 286872 0
#325, Section 2, Chenggung Road, Neihu 11490, Taipei
Ethics committee country [1] 286872 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 286872 0
Approval date [1] 286872 0
14/12/2010
Ethics approval number [1] 286872 0
099-05-204

Summary
Brief summary
Total intravenous anesthesia (TIVA) with continuous propofol infusion has been successfully used for liver transplantation (LT). In these reports, a significant increase in propofol plasma concentration was observed in the anhepatic phase; it may lead to over dosage of propofol and compromise the intraoperative hemodynamics. Target-controlled infusion (TCI) device allow anesthesiologists to provide excellent anesthesia by controlling the theoretical concentration of the drug. Wu et al., had demonstrated that the Marsh pharmacokinetic model of TCI is not suitable for LT patients, and suggested that anesthesiologists should use an effective parameter, such as the bispectral index (BIS), spectral entropy or auditory evoked potential (AEP) monitoring, as another guide of propofol to control the TCI pump during LT. In addition, regarding the propofol pharmacokinetics during the anhepatic phase, a case series advocates the usefulness of BIS monitoring to titrate propofol infusion when using TCI anesthesia.
The composite A-line autoregressive index (AAI) of the AEP monitoring has been studied as an adequate method to monitor anesthetic depth.

The aim of this study was to retrospectively investigate the influence of perioperative anesthetic management and postoperative recovery of TIVA with propofol anesthesia compared to inhalation anesthesia with desflurane during LT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33894 0
Address 33894 0
Country 33894 0
Phone 33894 0
Fax 33894 0
Email 33894 0
Contact person for public queries
Name 17141 0
Chueng-He Lu
Address 17141 0
Department of Anesthesiology
Tri-Service General Hospital
#325, Section 2, Chenggung Road, Neihu 114, Taipei
Country 17141 0
Taiwan, Province Of China
Phone 17141 0
+886-2-87927128
Fax 17141 0
+886-2-87927127
Email 17141 0
box.lu@msa.hinet.net
Contact person for scientific queries
Name 8069 0
Chueng-He Lu
Address 8069 0
Department of Anesthesiology
Tri-Service General Hospital
#325, Section 2, Chenggung Road, Neihu 114, Taipei
Country 8069 0
Taiwan, Province Of China
Phone 8069 0
+886-2-87927128
Fax 8069 0
+886-2-87927127
Email 8069 0
box.lu@msa.hinet.net

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary