UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Laryngeal injuries and intubation conditions with or without neuromuscular relaxant
Title of the study (Brief title)	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	Toshiyuki Nakanishi
Organization	JCHO Tokuyama Central Hospital
Division name	Anesthesiology
Address	1-1 Kohdacho, Shunan city
TEL	0834-28-4411
Email	nakanishi.anest@gmail.com

Public contact
Name of contact person	Toshiyuki Nakanishi
Organization	JCHO Tokuyama Central Hospital
Division name	Anesthesiology
Address	1-1 Kohdacho, Shunan city
TEL	0834-28-4411
Homepage URL
Email	nakanishi.anest@gmail.com

Sponsor
Institute	JCHO Tokuyama Central Hospital, Anesthesiology
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022892