UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039294
Receipt number R000044819
Scientific Title Influence of neuromuscular block by continuous dosing rocuronium during hepatectomy with occlusion of liver blood flow
Date of disclosure of the study information 2020/01/28
Last modified on 2023/08/16 14:20:29

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Basic information

Public title

Influence of neuromuscular block by continuous dosing rocuronium during hepatectomy with occlusion of liver blood flow

Acronym

Influence of neuromuscular block by continuous dosing rocuronium during hepatectomy with occlusion of liver blood flow

Scientific Title

Influence of neuromuscular block by continuous dosing rocuronium during hepatectomy with occlusion of liver blood flow

Scientific Title:Acronym

Influence of neuromuscular block by continuous dosing rocuronium during hepatectomy with occlusion of liver blood flow

Region

Japan


Condition

Condition

patients undergoing hepatectomy by continuous dosing rocuronium

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Comparing pharmacokinetics of continuous dosing rocuronium in pre and post occlusion of liver blood flow during hepatectomy

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluate duration time of continuous dosing rocuronium in pre and post occlusion of liver blood flow during hepatectomy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

continuous dose of rocuronium while occlusion of liver blood flow

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients undergo hepatectomy

Key exclusion criteria

patients with PS higher than 3 in ASA classification

Target sample size

12


Research contact person

Name of lead principal investigator

1st name mai
Middle name
Last name yamamoto

Organization

Nihon university school of medicine

Division name

department of anesthesiology

Zip code

173-8610

Address

30-1 Oyaguchi kamicho

TEL

03-3972-8111

Email

yamamoto.mai@nihon-u.ac.jp


Public contact

Name of contact person

1st name mai
Middle name
Last name yamamoto

Organization

Nihon university school of medicine

Division name

Department of anesthesiology

Zip code

173-8610

Address

30-1 Oyaguchi kamicho

TEL

03-3972-8111

Homepage URL


Email

yamamoto.mai@nihon-u.ac.jp


Sponsor or person

Institute

Nihon university

Institute

Department

Personal name



Funding Source

Organization

Nihon university

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

Nihon university school of medicine

Address

30-1 Oyaguchi kamicho

Tel

03-3972-8111

Email

yamamoto.mai@nihon-u.ac.jp


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

2020 Year 01 Month 28 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

Completed

Date of protocol fixation

2019 Year 11 Month 17 Day

Date of IRB

2019 Year 12 Month 17 Day

Anticipated trial start date

2020 Year 01 Month 28 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 01 Month 28 Day

Last modified on

2023 Year 08 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044819


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name