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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023936
Receipt No. R000027208
Scientific Title Study on the effect of the post-operative sore throat and hoarseness by ST9 stimulus
Date of disclosure of the study information 2016/09/06
Last modified on 2016/11/30

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Basic information
Public title Study on the effect of the post-operative sore throat and hoarseness by ST9 stimulus
Acronym Effect of the post-operative sore throat and hoarseness by ST9 stimulus
Scientific Title Study on the effect of the post-operative sore throat and hoarseness by ST9 stimulus
Scientific Title:Acronym Effect of the post-operative sore throat and hoarseness by ST9 stimulus
Region
Japan

Condition
Condition patients undergoing general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Tracheal intubation is an essential medical procedure in a surgery. It occurs sore throat and hoarseness frequently after intubation, and discomfort to the patient. Although ST9 is believed to be effective acupuncture points to sore throat and hoarseness, there has been no study whether the sore throat and hoarseness after tracheal intubation is reduced by ST9 stimulus. In this study we will evaluate the impact on the sore throat and hoarseness incidence after tracheal intubation due to the presence or absence of ST9 stimulus. After data collection, it performs statistical processing to analyze the results.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Data is statistically analyzed to the rate and severity of the sore throat and hoarseness by using the Fisher's exact test and the Mann-Whitney test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Seals with a projection,"Kori Spot"(SEIRIN), are attached to the left and right of ST9 after induction of anesthesia, and withdrawn before awakening.
Interventions/Control_2 control
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing elective general anesthesia
Key exclusion criteria Patients undergoing emergency surgery, obese (BMI35 or more) patients , and/or patients with disease in the skin of the neck
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Minami
Organization Osaka Medical College
Division name Depertment of Anesthesiology
Zip code
Address Daigaku-machi 2-7, Takatsuki, Osaka, Japan
TEL 072-683-1221
Email ane022@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Sano
Organization Osaka Medical College
Division name Depertment of Anesthesiology
Zip code
Address Daigaku-machi 2-7, Takatsuki, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email ane095@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 09 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
Incidences of postoperative sore throat and hoarseness were significantly lower in the ST9 stimulated group than in the Control 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
2016 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 14 Day
Last follow-up date
2016 Year 11 Month 30 Day
Date of closure to data entry
2016 Year 11 Month 30 Day
Date trial data considered complete
2016 Year 11 Month 30 Day
Date analysis concluded
2016 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 05 Day
Last modified on
2016 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027208

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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