UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019515 |
|---|---|
| Receipt number | R000022373 |
| Scientific Title | Examination of the procedures for suppressing endotracheal-induced adverse effects such as hemodynamic changes during intubation. |
| Date of disclosure of the study information | 2015/10/28 |
| Last modified on | 2018/11/16 16:33:04 |
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Basic information
Public title
Examination of the procedures for suppressing endotracheal-induced adverse effects such as hemodynamic changes during intubation.
Acronym
Examination of the procedures for suppressing endotracheal-induced adverse effects such as hemodynamic changes during intubation.
Scientific Title
Examination of the procedures for suppressing endotracheal-induced adverse effects such as hemodynamic changes during intubation.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Mikito Kawamata |
Organization
Shinshu University School of Medicine
Division name
Department of anesthesiology and resuscitrogy
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263372670
kawamata@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 Resuscitology
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263372670
Homepage URL
kumiko_m@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine
Institute
Department
Personal name
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
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 |
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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022373
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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