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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039294
Receipt No. 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 2020/12/15

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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
Institute Nihon university
Institute
Department

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 Open public recruiting
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
2020 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.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


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