UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004688 |
|---|---|
| Receipt number | R000005578 |
| Scientific Title | Acceleromyographic and Electromyographic Monitoring of rocuronium-induced neuromuscular block in anesthetized patients with and without diabetes mellitus |
| Date of disclosure of the study information | 2010/12/08 |
| Last modified on | 2010/12/08 16:12:34 |
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Basic information
Public title
Acceleromyographic and Electromyographic Monitoring of rocuronium-induced neuromuscular block in anesthetized patients with and without diabetes mellitus
Acronym
diabetes mellitus and neuromuscular block
Scientific Title
Acceleromyographic and Electromyographic Monitoring of rocuronium-induced neuromuscular block in anesthetized patients with and without diabetes mellitus
Scientific Title:Acronym
diabetes mellitus and neuromuscular block
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The degree of rocuronium-induced neuromuscular block is assessed electromyographically and acceleromyographically in diabetic patients, and examine whether recovery from neuromuscular block is delayed.
Basic objectives2
Others
Basic objectives -Others
To investigate whether supramaximal stimulating current, onset of neuromuscular block, and maximum degree of neuromuscular block in the diabetic patients differ from those in the non-diabetic patients.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
supramaximal stimulating current, onset of neuromuscular block, maximum degree of neuromuscular block, and recovery from neuromuscular block
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
To assess the level of neuromuscular block acceleromyographically in diabetic patients
Interventions/Control_2
To assess the level of neuromuscular block electromyographically in diabetic patients
Interventions/Control_3
To assess the level of neuromuscular block acceleromyographically in non-diabetic patients
Interventions/Control_4
To assess the level of neuromuscular block electromyographically in non-diabetic patients
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
diabetic patients and non-diabetic patients scheduled for surgical procedure under general anesthesia
Key exclusion criteria
patients with cardiac, hepatic, or renal disorder, and taking drugs known to affect the action of neuromuscular relaxant
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuhji Saitoh |
Organization
Tujinaka Hospital Kashiwanoha
Division name
Department of Anesthesiology
Zip code
Address
Department of Anesthesiology, Tsujinaka Hospital Kashiwanoha, 148-6, Kashiwanoha Campus, 178-2, Wakashiba, Kashiwa-City, Chiba, 277-0871, Japan
TEL
04-7137-3737
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuhji Saitoh |
Organization
Department of Anesthesiology, Tsujinaka Hospital Kashiwanoha
Division name
Department of Anesthesiology
Zip code
Address
TEL
04-7137-3737
Homepage URL
ysr311@auone.jp
Sponsor or person
Institute
Department of Anesthesiology, Tsujinaka Hospital Kashiwanoha
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Tsujinaka Hospital Kashiwanoha
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
辻仲病院柏の葉 麻酔科
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 08 | 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
| 2009 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 08 | Day |
Last modified on
| 2010 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005578
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| Registered date | File name |
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| Registered date | File name |
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