UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026994 |
|---|---|
| Receipt number | R000030952 |
| Scientific Title | The clinical research about anesthetic factors on NIM tube in thyroidectomy |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2018/11/05 17:51:47 |
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Basic information
Public title
The clinical research about anesthetic factors on NIM tube in thyroidectomy
Acronym
The clinical research about anesthetic factors on NIM tube in thyroidectomy
Scientific Title
The clinical research about anesthetic factors on NIM tube in thyroidectomy
Scientific Title:Acronym
The clinical research about anesthetic factors on NIM tube in thyroidectomy
Region
| Japan |
Condition
Condition
Thyroid carcinoma
Classification by specialty
| Endocrine surgery | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This research aim to establish a proper protocol of EMG tube for anesthetists, which can make thyroidectomy safer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
IONM results during surgery and the vocal code motion by fiberscopy in POD1
Key secondary outcomes
IONM result changes by sugammadex during surgery
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients of planned thyroidectomy with informed consent
Key exclusion criteria
a case which could not collect all observation data
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masae IWASAKI |
Organization
Nippon Medical School
Division name
Department of anesthesiology
Zip code
Address
1-1-5, Sendagi, Bunkyo, Tokyo JAPAN
TEL
0338222131
masae-a@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masae IWASAKI |
Organization
Nippon Medical School
Division name
Department of anesthesiology
Zip code
Address
1-1-5, Sendagi, Bunkyo, Tokyo JAPAN
TEL
0338222131
Homepage URL
masae-a@nms.ac.jp
Sponsor or person
Institute
Nippon Medical 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
| 2017 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Out of 62 patients, 39 patients (19 male and 20 female) were included in this study. Tube disposition was observed in 27 patients (69 %), and 22 of them had inward movement, shor%ening of the distance between the tube electrocodes and the carina.The disposition group tended to have a shorter sterno-cricoid distance (mean 43.8 mm, range 32.2-55.9) than control group (49.7 mm, 40.7-63.7, p=0.048).10 patients (26 %) had malfunction of vocal cord at postoperative day 1.In all ten patients, the hoarseness was disappeared within six months after the operation.
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
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
There was no significant difference by sugammadex administration.
Management information
Registered date
| 2017 | Year | 04 | Month | 14 | Day |
Last modified on
| 2018 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030952
| 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 |
