UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized, double-blind, parallel-group study to evaluate the effect of alkalized lidocaine on hemodynamic changes during tracheal intubation.
Title of the study (Brief title)	A randomized, double-blind, parallel-group study to evaluate the effect of alkalized lidocaine on hemodynamic changes during tracheal intubation.
Region	Japan

Condition
Condition	Patients who undergo surgeries under general anesthesia.
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to develop methods for prevention of intubation-induced adverse effects.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in blood pressure and heart rate during tracheal intubation.
Key secondary outcomes	The degree of sore throat assessed by using a visual analogue scale (VAS, 0-100 mm) and hoarseness, dysphonea, nausea and vomitting are systematically evaluated as present or absent just after and at 15 minutes and 24 hours after extubation.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Laryngotrachal application of lidocaine before tracheal intubation.
Interventions/Control_2	Laryngotrachal application of alkalized lidocaine before tracheal intubation.
Interventions/Control_3	Laryngotrachal application of saline before tracheal intubation.
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	Adult patients (ASA physical status I or II) who required a tracheal intubation during general anesthesia.
Key exclusion criteria	Patients with anticipated difficult airway, patients who scheduled for surgery with nasotracheal intubation, patients who were pretreated with beta-blockers, patients who scheduled for surgery with epidural anesthesia, spinal anesthesia or nerve block in addition to general anesthesia, pregnant or lactating women, and paients who are allergic to local anesthetics.
Target sample size	60

Research contact person
Name of lead principal investigator	Kumiko Ishida
Organization	Shinshu University School of Medicine
Division name	Department of anesthesiology and resuscitrogy
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263372670
Email	kumiko_m@shinshu-u.ac.jp

Public contact
Name of contact person	Kumiko Ishida
Organization	Shinshu University School of Medicine
Division name	Department of anesthesiology and resuscitrogy
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263372670
Homepage URL
Email	kumiko_m@shinshu-u.ac.jp

Sponsor
Institute	Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine
Institute
Department

Funding Source
Organization	Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine
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	信州大学医学部附属病院（長野県）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 07 Day
Anticipated trial start date	2016 Year 03 Month 25 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 22 Day
Last modified on	2018 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024862