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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046213
Receipt No. R000052740
Scientific Title Comparison of measured and predicted blood concentration of rocuronium in automatic infusion control
Date of disclosure of the study information 2021/11/29
Last modified on 2021/11/29

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Basic information
Public title Comparison of measured and predicted blood concentration of rocuronium in automatic infusion control
Acronym Comparison of measured and predicted blood concentration of rocuronium in automatic infusion control
Scientific Title Comparison of measured and predicted blood concentration of rocuronium in automatic infusion control
Scientific Title:Acronym Comparison of measured and predicted blood concentration of rocuronium in automatic infusion control
Region
Japan

Condition
Condition Condition with surgical indication in general anesthesia
Classification by specialty
Gastroenterology Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery
Breast surgery Obsterics and gynecology Dermatology
Oto-rhino-laryngology Orthopedics Urology
Cardiovascular surgery Plastic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Compare measured blood concentration with predicted blood concentration of rocuronium in automatic infusion control under four conditions.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes measured blood concentration and predicted blood concentration of rocuronium
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Collect atrial blood about 5ml at 4 times during surgery.
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
100 years-old >
Gender Male and Female
Key inclusion criteria Patient given surgery with total intravenous anesthesia.
Key exclusion criteria Patient can't use rocuronium, patient have severe liver or renal disfunction.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Nakanishi
Middle name
Last name Yuko
Organization University of Fukui Hospital
Division name Department of Anesthesiology and Reanimatology
Zip code 9101193
Address 23-3 Shimoaiduki, Matsuoka, Eiheijicho, Toshida gun, Fukui
TEL 0776613111
Email honjoh@u-fukui.ac.jp

Public contact
Name of contact person
1st name Nakanishi
Middle name
Last name Yuko
Organization University of Fukui Hospital
Division name Department of Anesthesiology and Reanimatology
Zip code 9101193
Address 23-3 Shimoaiduki, Matsuoka, Eiheijicho, Toshida gun, Fukui
TEL 0776613111
Homepage URL
Email honjoh@u-fukui.ac.jp

Sponsor
Institute Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical research support center
Address 23-3 Shimoaiduki, Matsuoka, Eiheijicho, Toshida gun, Fukui
Tel 0776613111
Email chiken@ml.u-fukui.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
2021 Year 11 Month 29 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 17
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
2018 Year 11 Month 01 Day
Date of IRB
2018 Year 11 Month 05 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2025 Year 03 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
2021 Year 11 Month 29 Day
Last modified on
2021 Year 11 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052740

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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