UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003461 |
|---|---|
| Receipt number | R000004190 |
| Scientific Title | Study of tympanic temperature changing during intravenous sedation for Dental implant surgery |
| Date of disclosure of the study information | 2010/04/07 |
| Last modified on | 2014/10/07 10:18:12 |
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Basic information
Public title
Study of tympanic temperature changing during intravenous sedation for Dental implant surgery
Acronym
Study of tympanic temperature changing during intravenous sedation
Scientific Title
Study of tympanic temperature changing during intravenous sedation for Dental implant surgery
Scientific Title:Acronym
Study of tympanic temperature changing during intravenous sedation
Region
| Japan |
Condition
Condition
patient of dental implant surgery
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A search of the influence that a change of the tympanic temperature gives to the awakening from an intravenous sedation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure, Pulse, SpO2, Tympanic temperature, Axillary temperature,
Bispectral index monitoring, Time when
we have begun to walk for the first time after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
the group which does not mind for a change of the tympanic temperature
Interventions/Control_2
The group which cares for a change of the tympanic temperature
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
There are taken informed concent among dental implant patient under iv sedation at Nippon Dental University Niigata hospital
Key exclusion criteria
Have lever or kidney disorder
Have heart disease over NIHA2
Take tranquizers regularly
Have drug,bean,egg,allergy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sano Kimito |
Organization
The Nippon Dental University school of life Dentistry at Niigata
Division name
Department of Dental Anesthesiology
Zip code
Address
1-8 Hamaura-cho,Chuo-ku,Niigata
TEL
025-267-1500
yamada@ngt.ndu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamada Nozomi |
Organization
The Nippon Dental University school of life Dentistry at Niigata
Division name
Department of Dental Anesthesiology
Zip code
Address
1-8 Hamaura-cho,Chuo-ku,Niigata
TEL
025-267-1500
Homepage URL
yamada@ngt.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University school of life Dentistry at Niigata
Institute
Department
Personal name
Funding Source
Organization
NIPRO Corporation
Organization
Division
Category of Funding Organization
Profit 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
日本歯科大学新潟病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | 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
| 2010 | Year | 04 | Month | 07 | Day |
Last modified on
| 2014 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004190
| Research Plan | |
|---|---|
| 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 |
