UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022811 |
|---|---|
| Receipt number | R000026123 |
| Scientific Title | Randomized controlled trial of desflurane vs. sevoflurane in pediatric liver transplant patients |
| Date of disclosure of the study information | 2016/06/21 |
| Last modified on | 2016/06/20 19:37:11 |
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Basic information
Public title
Randomized controlled trial of desflurane vs. sevoflurane in pediatric liver transplant patients
Acronym
Randomized controlled trial of desflurane vs. sevoflurane in pediatric liver transplant patients
Scientific Title
Randomized controlled trial of desflurane vs. sevoflurane in pediatric liver transplant patients
Scientific Title:Acronym
Randomized controlled trial of desflurane vs. sevoflurane in pediatric liver transplant patients
Region
| Japan |
Condition
Condition
Pediatric patients who are scheduled for living donor liver transplantation
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of two inhalation antethstics, desflurane and sevoflurane, on the length of intubation in pediatric patients after living donor liver transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of operating room extubation after pediatric living donor liver transplantation
Key secondary outcomes
1) Length of postoperative intubation
2) Length of Intensive care unit stay
3) Perioperative blood examination
4) Perioperative vital sign change
5) Perioperative infusion therapy volume
6) Perioperative urine output change
7) Ratio of postoperaitve infection
8) Ratio of postoperative rejection
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Anesthetic management with Desflurane
Interventions/Control_2
Anesthetic management with Sevoflurane
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
| Not applicable |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) patients who are scheduled for living donor liver transplantation at National Center for Child Health and Development, Tokyo, Japan; 2) patients weighted more than or equal to 6kg; 3) patients aged less than 16 years old; 4) patients whose informed consent is obtained from their guardians before operation
Key exclusion criteria
1) preoperative ICU management; 2) other organ complications caused by diseases other than the present liver illness; 3) allergy to either/both of inhalation anesthetic(s) or halogenated agents; 4) past history of malignant hyperthermia or family history of malignant hyperthermia; 5) metabolic disease; 6) acute liver failure; 7) pulmonary hypertension; 8) respiratory tract symptoms within 2 weeks before surgery; 9) asthma; 10) any cases inappropriate for the trial judged by surgeons or anesthesiologists in charge
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chiaki Baba |
Organization
National Center for Child Health and Development
Division name
Anesthesia and ICU
Zip code
Address
2-10-1 Okura Setagaya Tokyo
TEL
0334160181
karaki-c@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiaki Baba |
Organization
National Center for Child Health and Development
Division name
Anesthesia and ICU
Zip code
Address
2-10-1 Okura Setagaya Tokyo
TEL
0334160181
Homepage URL
karaki-c@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
独立行政法人国立成育医療研究センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2016 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 20 | Day |
Last modified on
| 2016 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026123
