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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026994
Receipt No. 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

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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
Email 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
Email masae-a@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030952

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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