UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study of oral bacterla and saliva stress during general anesthesia
Title of the study (Brief title)	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	Toshiaki Minami
Organization	Osaka Medical College
Division name	Anesthesiology
Address	2-7 Daigaku-machi, Takatsuk city
TEL	0726-84-6361
Email	ane022@poh.osaka-med.ac.jp

Public contact
Name of contact person	Nobuyasu Komasawa
Organization	Osaka Medical College
Division name	Anesthesiology
Address	2-7Daigaku-machi, Takatsuki city
TEL	0726-84-6361
Homepage URL
Email	ane078@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020372