UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the procedures for suppressing endotracheal-induced adverse effects such as hemodynamic changes during intubation.
Title of the study (Brief title)	Examination of the procedures for suppressing endotracheal-induced adverse effects such as hemodynamic changes during intubation.
Region	Japan

Condition
Condition	Patients (ASA physical status I or II) 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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Laryngotrachal application of lidocaine before intubation.
Interventions/Control_2	Laryngotrachal application of alkalized lidocaine before intubation.
Interventions/Control_3	Laryngotrachal application of saline before 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	Patients who required a tracheal intubation during general anesthesia.
Key exclusion criteria	Patients with anticipated difficult airway, patients who required a vasoactive agents after end of surgery, patients who were pretreated with beta-blockers.
Target sample size	60

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

Public contact
Name of contact person	Kumiko Ishida
Organization	Shinshu University School of Medicine
Division name	Department of Anesthesiology and Resuscitology
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

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 28 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 28 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	2015 Year 10 Month 27 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=R000022373