UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Tracheal intubating conditions using sevoflurane and remifentanil target-controlled infusions without muscle relaxant.
Title of the study (Brief title)	tracheal intubating conditions with remifentanil TCI.
Region	Japan

Condition
Condition	otological patients without muscle relaxant
Classification by specialty	Oto-rhino-laryngology Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aimed to determine the most appropriate dose of remifentanil required for intubation using target -controlled infusion(TCI).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Intubating score Blood pressure, heart rate of intubation Dose of vasopressor agent
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	remifentanil TCI 15 ng/ml(effect site concentration)
Interventions/Control_2	remifentanil TCI 10 ng/ml(effect site concentration)
Interventions/Control_3	remifentanil TCI 5 ng/ml(effect site concentration)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	otological patients without muscle relaxant
Key exclusion criteria	Patients who refuse to participate this study Patients who have severe cardiovascular disease
Target sample size	60

Research contact person
Name of lead principal investigator	Manabu Yoshimura
Organization	Tokuyama Central Hospital
Division name	Department of anesthesiology
Address	1-1 Kodaco, Shunan-city 745-0825
TEL	0834-22-4411
Email	manabu-ygc@umin.ac.jp

Public contact
Name of contact person	Manabu Yoshimura
Organization	Tokuyama Central Hospital
Division name	Department of Anesthesiology
Address	1-1 Kodacyo, Shunan-city
TEL	0834-22-4411
Homepage URL
Email	manabu-ygc@umin.ac.jp

Sponsor
Institute	Tokuyama Central Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Tokuyama Central Hospital
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	JCHO徳山中央病院（山口県）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 05 Day
Anticipated trial start date	2015 Year 11 Month 05 Day
Last follow-up date	2016 Year 04 Month 01 Day
Date of closure to data entry	2016 Year 04 Month 01 Day
Date trial data considered complete	2016 Year 04 Month 01 Day
Date analysis concluded	2016 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 11 Month 05 Day
Last modified on	2016 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000022706