Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000910808
Ethics application status
Approved
Date submitted
20/08/2012
Date registered
27/08/2012
Date last updated
27/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sevoflurane aggravate minimal hepatic encephalopath in cirrhosis patients
Scientific title
Sevoflurane aggravate minimal hepatic encephalopathy in cirrhosis patients compared to propofol
Secondary ID [1] 281065 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
minimal hepatic encephalopathy 287207 0
general anesthesia 287208 0
Condition category
Condition code
Anaesthesiology 287541 287541 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2-3% sevoflurane (to maintain bispectral index values 40-60) inhaled during the operation (2-4h, vary on a case by case basis depending on the operation).
Intervention code [1] 285521 0
Treatment: Drugs
Comparator / control treatment
administration of propofol through target controlled infusion at 4-8mg/kg/h (to maintain bispectral index values 40-60) during the operation
Control group
Active

Outcomes
Primary outcome [1] 287784 0
Minimal hepatic encephalopathy detected by 20% increase in the number connection test (NCT) score
Timepoint [1] 287784 0
2 day and 7 day after surgery
Secondary outcome [1] 298831 0
Minimal hepatic encephalopathy detected by 20% increase in the line tracing test (LTT) score
Timepoint [1] 298831 0
2 day and 7 day after surgery

Eligibility
Key inclusion criteria
patients who had evidence of cirrhosis by clinical, biochemical, and/or histological criteria with ASA class 1 or 2 scheduled for elective surgery
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with active bleeding or with overt encephalopathy, patients with known allergy to sedative, known significant respiratory disease, active neurological impairment, advanced or decompensated liver disease (CP score >9, Child-Pugh class C), ongoing alcohol or drug abuse, psychiatric illness, monocular vision, mental impairment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4495 0
China
State/province [1] 4495 0

Funding & Sponsors
Funding source category [1] 285848 0
Government body
Name [1] 285848 0
National Natural Science Foundation of China
Country [1] 285848 0
China
Primary sponsor type
Government body
Name
National Natural Science Foundation of China
Address
83 Shuangqing Road, Beijing 100085
Country
China
Secondary sponsor category [1] 284671 0
Hospital
Name [1] 284671 0
Eastern Hepatobiliary Surgery Hospital
Address [1] 284671 0
225 Changhai Road, Shanghai 200438
Country [1] 284671 0
China

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Patients with minimal hepatic encephalopathy (MHE) have impaired motor function and visuomotor cordination, which make them unsafe in their life. Evaluation of MHE stage in surgery patients with hepatic cirrhosis is an important problem for the inhalation of anesthetics. We have previously observed that sevoflurane induced increased MHE scores in non-hepatic surgery patients with cirrhosis, suggesting that inhaled anesthetics can. In this study, we try to demonstrate the effect of sevoflurane on MHE in cirrhosis patients by a randomized controlled clinical observation. This study would be helpful for the perioperative anesthetic application in patients with cirrhosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34597 0
Address 34597 0
Country 34597 0
Phone 34597 0
Fax 34597 0
Email 34597 0
Contact person for public queries
Name 17844 0
Xue-rong Miao
Address 17844 0
225 Changhai Road, Shanghai 200438, China.
Country 17844 0
China
Phone 17844 0
+86 13636551152
Fax 17844 0
Email 17844 0
[email protected]
Contact person for scientific queries
Name 8772 0
Xue-rong Miao
Address 8772 0
225 Changhai Road, Shanghai 200438, China.
Country 8772 0
China
Phone 8772 0
+86 13636551152
Fax 8772 0
Email 8772 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.