UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019812 |
|---|---|
| Receipt number | R000022892 |
| Scientific Title | Laryngeal injuries and intubation conditions with or without neuromuscular relaxant |
| Date of disclosure of the study information | 2015/11/16 |
| Last modified on | 2018/05/19 12:27:48 |
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Basic information
Public title
Laryngeal injuries and intubation conditions with or without neuromuscular relaxant
Acronym
Intubation with or without neuromuscular relaxant
Scientific Title
Laryngeal injuries and intubation conditions with or without neuromuscular relaxant
Scientific Title:Acronym
Intubation with or without neuromuscular relaxant
Region
| Japan |
Condition
Condition
Patients undergo general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Non-inferiority trials test whether tracheal intubation without neuromuscular relaxant is not unacceptably worse than with neuromuscular relaxant using remifentanil and video laryngoscopy.
Expected hoarseness on postoperative day 2 = 10%
Margin for non-inferior trial = 10%
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hoarseness on postoperative day 2
Key secondary outcomes
intubation condition
postoperative sore throat
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intubation with neuromuscular relaxant
Interventions/Control_2
Intubation without neuromuscular relaxant
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
Patient who need tracheal intubation during general anesthesia
Key exclusion criteria
Patient for emergency operation
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nakanishi |
Organization
JCHO Tokuyama Central Hospital
Division name
Anesthesiology
Zip code
Address
1-1 Kohdacho, Shunan city
TEL
0834-28-4411
nakanishi.anest@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nakanishi |
Organization
JCHO Tokuyama Central Hospital
Division name
Anesthesiology
Zip code
Address
1-1 Kohdacho, Shunan city
TEL
0834-28-4411
Homepage URL
nakanishi.anest@gmail.com
Sponsor or person
Institute
JCHO Tokuyama Central Hospital, Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
JCHO Tokuyama Central Hospital
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 | 11 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 16 | Day |
Last modified on
| 2018 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022892
