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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021563
Receipt No. R000024862
Scientific Title A randomized, double-blind, parallel-group study to evaluate the effect of alkalized lidocaine on hemodynamic changes during tracheal intubation.
Date of disclosure of the study information 2016/03/25
Last modified on 2018/11/16

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Basic information
Public title A randomized, double-blind, parallel-group study to evaluate the effect of alkalized lidocaine on hemodynamic changes during tracheal intubation.
Acronym A randomized, double-blind, parallel-group study to evaluate the effect of alkalized lidocaine on hemodynamic changes during tracheal intubation.
Scientific Title A randomized, double-blind, parallel-group study to evaluate the effect of alkalized lidocaine on hemodynamic changes during tracheal intubation.
Scientific Title:Acronym 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
1st name
Middle name
Last name Kumiko Ishida
Organization Shinshu University School of Medicine
Division name Department of anesthesiology and resuscitrogy
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano
TEL 0263372670
Email kumiko_m@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kumiko Ishida
Organization Shinshu University School of Medicine
Division name Department of anesthesiology and resuscitrogy
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 03 Month 07 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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