UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical research about anesthetic factors on NIM tube in thyroidectomy
Title of the study (Brief title)	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	Masae IWASAKI
Organization	Nippon Medical School
Division name	Department of anesthesiology
Address	1-1-5, Sendagi, Bunkyo, Tokyo JAPAN
TEL	0338222131
Email	masae-a@nms.ac.jp

Public contact
Name of contact person	Masae IWASAKI
Organization	Nippon Medical School
Division name	Department of anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000030952