UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024224 |
|---|---|
| Receipt number | R000027893 |
| Scientific Title | The significance to maintain a high end-tidal carbon dioxide concentration in the process of emergence from general anesthesia and extubation |
| Date of disclosure of the study information | 2016/09/29 |
| Last modified on | 2018/06/05 10:52:25 |
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Basic information
Public title
The significance to maintain a high end-tidal carbon dioxide concentration in the process of emergence
from general anesthesia and extubation
Acronym
The emergence from general anesthesia and end-tidal carbon dioxide concentration
Scientific Title
The significance to maintain a high end-tidal carbon dioxide concentration in the process of emergence
from general anesthesia and extubation
Scientific Title:Acronym
The emergence from general anesthesia and end-tidal carbon dioxide concentration
Region
| Japan |
Condition
Condition
emergence from general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the process of emergence from general anesthesia, stimulation of the tracheal tube causespatient's pain and large change of vital. During extubation, it can reduce adverse events by keeping high end-tidal carbon dioxide concentration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In the emergence from the general anesthesia and extubation, I evaluate the patient's pain .I compare high group (more than 50mmHG) and low group (less than 50mmHG).
Key secondary outcomes
Vital change, the number of coughing, sore throat
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
General anesthesia, tracheal intubation
Key exclusion criteria
Epidural anesthesia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamashita |
Organization
Kobe city general hospital
Division name
Department of anesthesiology
Zip code
Address
Minatojimaminamimachi2-1-1 chuou-ku Kobe city, Japan
TEL
078-302-4321
cantateveritas@kcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamashita |
Organization
Kobe city general hospital
Division name
Department of anesthesiology
Zip code
Address
Minatojimaminamimachi2-1-1 chuou-ku Kobe city, Japan
TEL
078-302-4321
Homepage URL
cantateveritas@kcho.jp
Sponsor or person
Institute
Kobe city general hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe city general hospital
Organization
Division
Category of Funding Organization
Local Government
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
神戸市立医療センター中央市民病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Pain evaluation at the time of emergence from general anesthesia
Management information
Registered date
| 2016 | Year | 09 | Month | 29 | Day |
Last modified on
| 2018 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027893
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
