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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007021
Receipt No. R000008280
Scientific Title randomized, unblinded comparison of monitoring of neuromuscular block at the upper lip, corrugator supercilii muscle, and thumb
Date of disclosure of the study information 2012/03/01
Last modified on 2013/04/01

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Basic information
Public title randomized, unblinded comparison of monitoring of neuromuscular block at the upper lip, corrugator supercilii muscle, and thumb
Acronym neuromuscular monitoring at the upper lip, corrugator supercilii muscle, and thumb
Scientific Title randomized, unblinded comparison of monitoring of neuromuscular block at the upper lip, corrugator supercilii muscle, and thumb
Scientific Title:Acronym neuromuscular monitoring at the upper lip, corrugator supercilii muscle, and thumb
Region
Japan

Condition
Condition surgical procedure under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the monitoring of neuromuscular block or the usefulness of the monitoring at the upper lip, corrugator supercilii muscle, and thumb
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Supramaximal stimulating current, onset of neuromuscular block, and recovery of neuromuscular block at the upper lip, corrugator supercilii muscle, and thumb
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver Other
Interventions/Control_1 To study the monitoring of neuromuscular block at the atypical part of patients, i.e., upper lip
Interventions/Control_2 To study the monitoring of neuromuscular block at the atypical part of patients, i.e., corrugator supercilii muscle
Interventions/Control_3 To study the monitoring of neuromuscular block at the typical part of patients, i.e., thumb
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adult patients scheduled for elective surgical procedure under general anesthesia
Key exclusion criteria Patients with neuromuscular, cardiac, hepatic, renal, or metabolic disease, and patients receiving drugs known to affect the action of neuromuscular block
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rui Yajima
Organization Tokyo Women's Medical University, Yachiyo Medical Center
Division name Department of Anesthesiology
Zip code
Address 477-96, Owada-Shinden, Yachiyo-City, Chiba, 276-8524, Japan
TEL 047-450-6000
Email

Public contact
Name of contact person
1st name
Middle name
Last name Rui Yajima
Organization Tokyo Women's Medical University, Yachiyo Medical Center
Division name Department of Anesthesiology
Zip code
Address
TEL
Homepage URL
Email rui_yajima@yahoo.co.jp

Sponsor
Institute Tokyo Women's Medical University, Department of Anesthesiology
Institute
Department

Funding Source
Organization Tokyo Women's Medical University, Department of Anesthesiology
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 01 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
2012 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 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
2012 Year 01 Month 05 Day
Last modified on
2013 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008280

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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