UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038949 |
|---|---|
| Receipt number | R000044414 |
| Scientific Title | Comparison of postoperative liver function between total intravenous anesthesia and inhalation anesthesia in patients with preoperatively elevated liver transaminase levels: a single-center retrospective cohort study |
| Date of disclosure of the study information | 2019/12/21 |
| Last modified on | 2020/06/22 09:34:48 |
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Basic information
Public title
Comparison of postoperative liver function between total intravenous anesthesia and inhalation anesthesia in patients with preoperatively elevated liver transaminase levels: a single-center retrospective cohort study
Acronym
Effects of TIVA versus inhalation anesthesia on elevated LFT
Scientific Title
Comparison of postoperative liver function between total intravenous anesthesia and inhalation anesthesia in patients with preoperatively elevated liver transaminase levels: a single-center retrospective cohort study
Scientific Title:Acronym
Effects of TIVA versus inhalation anesthesia on elevated LFT
Region
| Asia(except Japan) |
Condition
Condition
Patients with preoperatively elevated liver transaminase levels who underwent surgery under general anesthesiaanesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This retrospective study aimed to investigate the effect of total intravenous anesthesia versus inhalation anesthesia on the postoperative liver function in patients with preoperatively elevated liver transaminase levels who underwent surgery under general anesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The changes (%, increase or decrease) in liver enzyme (ALT) levels measured within 24 hours before and after surgery
Key secondary outcomes
30-day mortality, length of postoperative hospital stay
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 19 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients that featured elevated preoperative liver enzymes (AST > 40 U/L or ALT > 40 U/L) within 24 hour before operation in non-hepatic surgeries
Key exclusion criteria
patients with normal range of preoperative LFT results,
hepatic surgery,heart surgery and Cesarean section
Target sample size
626
Research contact person
Name of lead principal investigator
| 1st name | Byung Gun |
| Middle name | |
| Last name | Lim |
Organization
Korea University Guro Hospital
Division name
Seoul
Zip code
08308
Address
148, Gurodong-ro, Guro-gu, Seoul
TEL
82-2-2626-3231
bglim9205@korea.ac.kr
Public contact
Name of contact person
| 1st name | Seok Kyeong |
| Middle name | |
| Last name | Oh |
Organization
Korea University Guro Hospital
Division name
Seoul
Zip code
08308
Address
148, Gurodong-ro, Guro-gu, Seoul
TEL
82-2-2626-1437
Homepage URL
nanprayboy@korea.ac.kr
Sponsor or person
Institute
Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Korea University Guro Hospital
Address
148, Gurodong-ro, Guro-gu, Seoul 08308, Korea
Tel
+82 2 2626 1635
ssessong@korea.ac.kr
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
doi: 10.2147/TCRM.S248441
Publication of results
Published
Result
URL related to results and publications
doi: 10.2147/TCRM.S248441
Number of participants that the trial has enrolled
730
Results
In 730 patients (TIVA: n=138; INHA: n=592), postoperative AST and ALT changes were significantly lower in the TIVA group than in the INHA group. After 1:4 propensity score matching (TIVA: n=94; INHA: n=376), only the ALT change was significantly lower after TIVA than after INHA.
Results date posted
| 2020 | Year | 06 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The baseline characteristics were comparable, except for higher comorbidity rates in the TIVA group.
Participant flow
A total of 12,372 patients was operated under general anesthesia between December 2016 and November 2017. Among these, 11,282 patients with preoperative LFT values within the normal range were excluded. Thereafter, we excluded 29 patients aged <18 years, 109 patients who were undergoing hepatic surgery (n = 61), cardiac surgery (n = 25), and cesarean section (n = 23), 4 patients with neuromuscular disease, and 218 patients whose LFT values were not measured within 24 hrs after surgery. Finally, 730 patients were analyzed in this study.
Adverse events
Mortality cases of 21 had been identified during the follow-up period of this retrospective study. Among the 21 patients who died, 8 patients died of bleeding; 4 patients, cancer metastasis; 4 patients, sepsis; 3 patients; respiratory failure; and 1 patient, liver cirrhosis aggravation to hepatic encephalopathy.
Outcome measures
We compared the changes (% increase or decrease) in the liver enzyme levels (ALT and AST) measured within 24 hrs before and after surgery. The liver enzyme level measured at the time closest to the start of the surgery within 24 hrs before surgery was considered the preoperative value, and the level measured at the time closest to the end of the surgery within 24 hrs after surgery was considered the postoperative value.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study using datasets collected from medical records and clinical database.
Management information
Registered date
| 2019 | Year | 12 | Month | 21 | Day |
Last modified on
| 2020 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044414
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