UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of method to administer lidocaine into trachea
Title of the study (Brief title)	Influence of method to administer lidocaine into trachea
Region	Japan

Condition
Condition	patient undergoing elective surgery under general anesthesia
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim is to examine the effect of method to administer lidocaine into trachea on pharmacokinetics of lidocaine.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	plasma concentration of lidocaine
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	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	conventional device for tracheal administration
Interventions/Control_2	novel device for tracheal administration
Interventions/Control_3
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	patients undergoing elective surgery under general anesthesia
Key exclusion criteria	significant heart, respiratory, hepatic, or renal impairment; body mass index greater than 30
Target sample size	50

Research contact person
Name of lead principal investigator	Kenichi Masui
Organization	National Defense Medical College Hospital
Division name	Department of Anesthesiology
Address	Namiki 3-2, Tokorozawa, Saitama, Japan
TEL	04-2995-1511
Email	kenichi@masuinet.com

Public contact
Name of contact person	Kenichi Masui
Organization	National Defense Medical College
Division name	Department of Anesthesiology
Address	Namiki 3-2, Tokorozawa, Saitama, Japan
TEL	04-2995-1511
Homepage URL
Email	kenichi@masuinet.com

Sponsor
Institute	National Defense Medical College
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	National Defense Medical College and Departmental Funding
Organization
Division
Category of Funding Organization
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	2011 Year 08 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 03 Month 01 Day
Anticipated trial start date	2011 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 08 Month 23 Day
Last modified on	2016 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000007364