UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007021 |
|---|---|
| Receipt number | 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 18:11:13 |
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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
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
rui_yajima@yahoo.co.jp
Sponsor or person
Institute
Tokyo Women's Medical University, Department of Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008280
