UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045758 |
|---|---|
| Receipt number | R000051942 |
| Scientific Title | The influence of aging on the time lag of the detection of twitch response between subjective and objective neuromuscular monitoring. |
| Date of disclosure of the study information | 2021/10/16 |
| Last modified on | 2021/10/15 10:09:07 |
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Basic information
Public title
The influence of aging on the time lag of the detection of twitch response between subjective and objective neuromuscular monitoring.
Acronym
Aging and the time lag between subjective and objective neuromuscular monitoring.
Scientific Title
The influence of aging on the time lag of the detection of twitch response between subjective and objective neuromuscular monitoring.
Scientific Title:Acronym
Aging and the time lag between subjective and objective neuromuscular monitoring.
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test a hypothesis that aging effects the time lag between the detection (or the disappearance) of twitch response evaluated subjectively and that evaluated objectively.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time lag of the onset and duration of rocuronium between subjective and objective neuromuscular monitoring.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients scheduled for surgeries under general anesthesia
Key exclusion criteria
1)Patients having allergic factors to rocuronium or sugammadex
2)BMI 30 kg/m2 and above or below 18.5 kg/m2
3)cirrhosis, hepatitis
4)heart failure
5)renal dysfunction
6)neuromuscular disorder
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Fujimoto |
Organization
Nishinihon Hospital
Division name
Department of anesthesiology
Zip code
861-8034
Address
3-20-1, Hattannda, Higashiku, Kumamoto-City, Kumamoto
TEL
0963801111
mfujimoto.kmm@gmail.com
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Fujimoto |
Organization
Nishinihon Hospital
Division name
Department of anesthesiology
Zip code
861-8034
Address
3-20-1, Hattannda, Higashiku, Kumamoto-City, Kumamoto
TEL
0963801111
Homepage URL
mfujimoto.kmm@gmail.com
Sponsor or person
Institute
Nishinihon Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nishinihon Hospital IRB
Address
3-20-1, Hattannda, Higashiku, Kumamoto-City, Kumamoto
Tel
0963801111
jimubu@nishinihon.or.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 | 10 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
onset time, duration time, Intubation condition.
Management information
Registered date
| 2021 | Year | 10 | Month | 15 | Day |
Last modified on
| 2021 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051942
