UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017489 |
|---|---|
| Receipt number | R000019841 |
| Scientific Title | Efficacy of muscle relaxant for tracheal intubation with AWS. |
| Date of disclosure of the study information | 2015/05/11 |
| Last modified on | 2015/06/12 11:11:21 |
* 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
Efficacy of muscle relaxant for tracheal intubation with AWS.
Acronym
Muscle relaxant for AWS intubation
Scientific Title
Efficacy of muscle relaxant for tracheal intubation with AWS.
Scientific Title:Acronym
Muscle relaxant for AWS intubation
Region
| Japan |
Condition
Condition
Patient who undergo general anesthesia with tracehalintubation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the muscle relaxant efficacy for intubation efficacy for tracehal intubation with AWS
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intubation time, intubation success rate
laryngoscopy
insertion times of tube through glottis
glottis closeure degree
Key secondary outcomes
postoperative pharyngeal pain, hoarsenee
subjective difficulty
vital sign change during intubation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administer muscle relaxant for tracehal intubation with AWS
Interventions/Control_2
Not Administer muscle relaxant for tracehal intubation with AWS
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
Patient who need tracheal intubation during general anesthesia
Key exclusion criteria
Patient for emergency operation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuk city
TEL
0726-84-6361
ane022@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Komasawa Nobuyasu |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7Daigaku-machi, Takatsuki city
TEL
0726-84-6361
Homepage URL
ane078@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
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 | 05 | Month | 11 | 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
Muscle relaxant faciliated AWS-mediated tracheal intubation by shortening the intubation time, VAS for laryngoscopy. The laryngoscopy did not change by muscle relaxant adminstration
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
| 2015 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 10 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 12 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 20 | Day |
Other
Other related information
Hoarseness was sinigificantly smaller in MR grpup compared to C group
Management information
Registered date
| 2015 | Year | 05 | Month | 11 | Day |
Last modified on
| 2015 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019841
