UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018212 |
|---|---|
| Receipt number | R000020372 |
| Scientific Title | Observational study of oral bacterla and saliva stress during general anesthesia |
| Date of disclosure of the study information | 2015/07/06 |
| Last modified on | 2018/07/22 18:24:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observational study of oral bacterla and saliva stress during general anesthesia
Acronym
Oral bacteria and saliva stresss during general anesthesia
Scientific Title
Observational study of oral bacterla and saliva stress during general anesthesia
Scientific Title:Acronym
Oral bacteria and saliva stresss during general anesthesia
Region
| Japan |
Condition
Condition
Patient who undergo general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of oral saliva and bacterial number during general anesthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacterial number, species
Stress marker transition
Key secondary outcomes
Vital sign
Patient background
postoperative symptoms
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient who undergo generla anesthesia
Key exclusion criteria
Patient who does not undergo general anesthesia
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuk city
TEL
0726-84-6361
ane022@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyasu Komasawa |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7Daigaku-machi, Takatsuki city
TEL
0726-84-6361
Homepage URL
ane078@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 07 | 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
Saliva cortisol was significantly smaller after general anesthesia compared to before anesthesia. The number of oral bacteria did not significantly differ between before and after general anesthesia. Oral care group showed significantly smaller bacteria and cortisol value compared to no treated group.
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 | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 07 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 14 | Day |
Date analysis concluded
Other
Other related information
Evaluationg the number of bacteria and stress markers before and after general anesthesia.
Management information
Registered date
| 2015 | Year | 07 | Month | 06 | Day |
Last modified on
| 2018 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020372
