UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018194 |
|---|---|
| Receipt number | R000021068 |
| Scientific Title | Study the pharmacodynamics of neuromuscular blockade and selective relaxant-binding agent using the body composition measuring device in obese patients. |
| Date of disclosure of the study information | 2015/07/05 |
| Last modified on | 2016/03/25 16:24:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study the pharmacodynamics of neuromuscular blockade and selective
relaxant-binding agent using the body composition measuring device in obese patients.
Acronym
The pharmacodynamics of rocuronium and sugammadex using the body composition measuring device in obese patients.
Scientific Title
Study the pharmacodynamics of neuromuscular blockade and selective
relaxant-binding agent using the body composition measuring device in obese patients.
Scientific Title:Acronym
The pharmacodynamics of rocuronium and sugammadex using the body composition measuring device in obese patients.
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We research the appropriate dosage of neuromuscular blockade and selective relaxant binding agents, onset time, duration of action, recovery time, and the remaining muscle relaxation state, in obese patients using body composition meter.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Train of four ratio.
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
BMI25 kg/m2 or more in the obesity, American Society of Anesthesiologists Physical States in class I-III, the men and women of more than 20-year-old.
Patients undergoing surgery under general anesthesia.
Key exclusion criteria
American Society of Anesthesiologists Physical States in class over IV.
Under 20-year-old. Pregnant woman. Patients who do not obtain their consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nami Kakuta |
Organization
Institute of Biomedical Sciences Tokushima University Graduate School
Division name
Department of Anesthesiology
Zip code
Address
770-8503
TEL
088-633-7181
kakuta.nami@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nami Kakuta |
Organization
Institute of Biomedical Sciences Tokushima University Graduate School
Division name
Department of Anesthesiology
Zip code
Address
3-18-15 Kuramoto, Tokushima
TEL
088-633-7181
Homepage URL
kakuta.nami@tokushima-u.ac.jp
Sponsor or person
Institute
Institute of Biomedical Sciences Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2015 | Year | 07 | 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
| 2015 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | 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
USe of body compositionmeter.
Management information
Registered date
| 2015 | Year | 07 | Month | 05 | Day |
Last modified on
| 2016 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021068
