UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial of desflurane vs. sevoflurane in pediatric liver transplant patients
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Chiaki Baba
Organization	National Center for Child Health and Development
Division name	Anesthesia and ICU
Address	2-10-1 Okura Setagaya Tokyo
TEL	0334160181
Email	karaki-c@ncchd.go.jp

Public contact
Name of contact person	Chiaki Baba
Organization	National Center for Child Health and Development
Division name	Anesthesia and ICU
Address	2-10-1 Okura Setagaya Tokyo
TEL	0334160181
Homepage URL
Email	karaki-c@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 03 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026123