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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name