UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019648 |
|---|---|
| Receipt number | R000022706 |
| Scientific Title | Tracheal intubating conditions using sevoflurane and remifentanil target-controlled infusions without muscle relaxant. |
| Date of disclosure of the study information | 2015/11/05 |
| Last modified on | 2016/04/11 14:15:03 |
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Basic information
Public title
Tracheal intubating conditions using sevoflurane and remifentanil target-controlled infusions without muscle relaxant.
Acronym
tracheal intubating conditions with remifentanil TCI.
Scientific Title
Tracheal intubating conditions using sevoflurane and remifentanil target-controlled infusions without muscle relaxant.
Scientific Title:Acronym
tracheal intubating conditions with remifentanil TCI.
Region
| Japan |
Condition
Condition
otological patients without muscle relaxant
Classification by specialty
| Oto-rhino-laryngology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to determine the most appropriate dose of remifentanil required for intubation using target -controlled infusion(TCI).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intubating score
Blood pressure, heart rate of intubation
Dose of vasopressor agent
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
remifentanil TCI 15 ng/ml(effect site concentration)
Interventions/Control_2
remifentanil TCI 10 ng/ml(effect site concentration)
Interventions/Control_3
remifentanil TCI 5 ng/ml(effect site concentration)
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
otological patients without muscle relaxant
Key exclusion criteria
Patients who refuse to participate this study
Patients who have severe cardiovascular disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Yoshimura |
Organization
Tokuyama Central Hospital
Division name
Department of anesthesiology
Zip code
Address
1-1 Kodaco, Shunan-city 745-0825
TEL
0834-22-4411
manabu-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Yoshimura |
Organization
Tokuyama Central Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-1 Kodacyo, Shunan-city
TEL
0834-22-4411
Homepage URL
manabu-ygc@umin.ac.jp
Sponsor or person
Institute
Tokuyama Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokuyama Central Hospital
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
JCHO徳山中央病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 05 | 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
| 2015 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 05 | Day |
Last modified on
| 2016 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022706
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
