UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011581 |
|---|---|
| Receipt number | R000013544 |
| Scientific Title | A clinical study for the staircase phenomenon which interferes with the monitoring of the degree of neuromuscular block during general anesthesia |
| Date of disclosure of the study information | 2013/10/05 |
| Last modified on | 2017/02/27 11:31:44 |
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Basic information
Public title
A clinical study for the staircase phenomenon which interferes with the monitoring of the degree of neuromuscular block during general anesthesia
Acronym
A study for the staircase phenomenon which interferes with the monitoring of neuromuscular block
Scientific Title
A clinical study for the staircase phenomenon which interferes with the monitoring of the degree of neuromuscular block during general anesthesia
Scientific Title:Acronym
A study for the staircase phenomenon which interferes with the monitoring of neuromuscular block
Region
| Japan |
Condition
Condition
diseases which need surgical procedure under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the staircase phenomenon which prevents proper monitoring of neuromuscular block, and make the monitoring of neuromuscular block appropriate
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the hypothesis that the staircase phenomenon only rarely interferes with proper monitoring of neuromuscular block
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
8
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
To investigate the time course of the degree of the staircase phenomenon in patients with hypertension receiving calcium channel blockers
Interventions/Control_2
To investigate the time course of the degree of the staircase phenomenon in patients with diabetes mellitus
Interventions/Control_3
To investigate the time course of the degree of the staircase phenomenon in patients with dyslipidemia
Interventions/Control_4
To investigate the time course of the degree of the staircase phenomenon in healthy control patients
Interventions/Control_5
To examine the level of recovery from neuromuscular block after surgical procedure in patients with hypertension receiving calcium channel blockers
Interventions/Control_6
To examine the level of recovery from neuromuscular block after surgical procedure in patients with diabetes mellitus
Interventions/Control_7
To examine the level of recovery from neuromuscular block after surgical procedure in patients with dyslipidemia
Interventions/Control_8
To examine the level of recovery from neuromuscular block after surgical procedure in healthy control patients
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with hypertension receiving calcium channel blockers, those with diabetes mellitus, those with dyslipidemia, and healthy control patients
Key exclusion criteria
Patients with cardiac, hepatic, or renal disorder, and those with metabolic diseases other than diabetes mellitus or dyslipidemia
Target sample size
144
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuhji Saitoh |
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
TEL
047-450-6000
ysa@kcf.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuhji Saitoh |
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
TEL
047-450-6000
Homepage URL
ysa@kcf.biglobe.ne.jp
Sponsor or person
Institute
Tokyo Women's Medical University, Yachiyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University, Yachiyo Medical Center
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
| 2013 | Year | 10 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 08 | 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
| 2013 | Year | 08 | Month | 26 | Day |
Last modified on
| 2017 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013544
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| Registered date | File name |
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| Registered date | File name |
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