UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007459 |
|---|---|
| Receipt number | R000008796 |
| Scientific Title | Cough reflex under intravenous sedation during dental implant surgery |
| Date of disclosure of the study information | 2012/03/06 |
| Last modified on | 2013/01/07 20:34:18 |
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Basic information
Public title
Cough reflex under intravenous sedation during dental implant surgery
Acronym
Cough reflex under intravenous sedation during dental implant surgery
Scientific Title
Cough reflex under intravenous sedation during dental implant surgery
Scientific Title:Acronym
Cough reflex under intravenous sedation during dental implant surgery
Region
| Japan |
Condition
Condition
missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate how often the cough reflex occurs, what is associated with the occurrence of the cough reflex, and what situations induce it.
Basic objectives2
Others
Basic objectives -Others
observational investigation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
surgical procedure, surgical region
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who are scheduled for dental implant surgery under intravenous sedation
Key exclusion criteria
patients with dysphagia
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hanamoto |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthsiology
Zip code
Address
1-8, Yamadaoka, Suita, Osaka
TEL
06-6879-2972
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hanamoto |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthsiology
Zip code
Address
1-8, Yamadaoka, Suita, Osaka
TEL
06-6879-2972
Homepage URL
Sponsor or person
Institute
Osaka University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Osaka University
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
| 2012 | Year | 03 | Month | 06 | 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
| 2009 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | 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
Intraoperatively, if the patient coughed, the surgical procedure and the area being stimulated are recorded.
Management information
Registered date
| 2012 | Year | 03 | Month | 06 | Day |
Last modified on
| 2013 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008796
| 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 |
