UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015776 |
|---|---|
| Receipt number | R000018349 |
| Scientific Title | Effect of warming on genral anesthetics requirement for loss of consciousness |
| Date of disclosure of the study information | 2014/11/29 |
| Last modified on | 2019/01/21 11:57:28 |
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Basic information
Public title
Effect of warming on genral anesthetics requirement for loss of consciousness
Acronym
Effect of warming on general anesthesia induction
Scientific Title
Effect of warming on genral anesthetics requirement for loss of consciousness
Scientific Title:Acronym
Effect of warming on general anesthesia induction
Region
| Japan |
Condition
Condition
patient for general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination on the effect of warming on general anesthestics requireent for loss of consciousness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood concentration of general anethetics on loss of consciousness
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Heated forced air at 43 degrees is delivered wihtin a full-body field using a warming unit
Interventions/Control_2
Putting on warming unit
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patient with ASA physical classification of 1 or 2 who are scheduled surgery under general anesthesia
Key exclusion criteria
diabetic mellitus
use of psychotropic agent
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikito Kawamata |
Organization
Shinshu University school of medicine
Division name
the department of anesthesiology and resuscitology
Zip code
Address
3-1-1 Asahi Matumoto city Nagano
TEL
0263-37-2670
masui@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norimasa Hishinuma |
Organization
Shinshu University school of medicine
Division name
the department of anesthesiology and resuscitology
Zip code
Address
3-1-1 Asahi Matumoto city Nagano
TEL
0263-37-2670
Homepage URL
kojiromasakado@gmail.com
Sponsor or person
Institute
Shinshu University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University school of medicine
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 11 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | 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
| 2014 | Year | 11 | Month | 28 | Day |
Last modified on
| 2019 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018349
