UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029956 |
|---|---|
| Receipt number | R000034222 |
| Scientific Title | Appropriate muscular relaxation level during positive pressure ventilation using supraglottic airway devices |
| Date of disclosure of the study information | 2017/11/15 |
| Last modified on | 2019/06/28 15:15:36 |
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Basic information
Public title
Appropriate muscular relaxation level
during positive pressure ventilation using
supraglottic airway devices
Acronym
Supraglottic airway device and muscle
relaxation
Scientific Title
Appropriate muscular relaxation level
during positive pressure ventilation using
supraglottic airway devices
Scientific Title:Acronym
Supraglottic airway device and muscle
relaxation
Region
| Japan |
Condition
Condition
patients under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Insertion of supraglottic device was able to be performed without muscular relaxant. Laryngospasm sometimes occurs during and after an insertion of supraglotitc device when muscular relaxant is not used. Although the use of muscular relaxant may make an insertion of supraglotic device safe, we do not know an appropriate muscle relaxation level during an insertion of supraglottic device. In the present study, we will evaluate an appropriate level of muscle relaxation during an insertion of supraglottic device.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between muscular relaxation level and leak pressure of supraglottic device.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
dose of rocuronium
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients under general anesthesia
Key exclusion criteria
ineligible patients
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Yamamoto |
Organization
Kumamoto University Hospital
Division name
Anesthesiology
Zip code
Address
1-1-1 Honjyo, chuo-ku, Kumamoto-shi
TEL
0963735275
yamyam@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Yamamoto |
Organization
Kumamoto University Hospital
Division name
Anesthesiology
Zip code
Address
1-1-1 Honjyo, chuo-ku, Kumamoto-shi
TEL
096-373-5275
Homepage URL
http://kuma-ma.com/
yamyam@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology
Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
熊本大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 15 | 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
| 2017 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 13 | Day |
Last modified on
| 2019 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034222
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
