UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the effect of the post-operative sore throat and hoarseness by ST9 stimulus
Title of the study (Brief title)	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with a projection,"Kori Spot"(SEIRIN), are attached to the left and right of ST9 after induction of anesthesia, and withdrawn before awakening.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	Toshiaki Minami
Organization	Osaka Medical College
Division name	Depertment of Anesthesiology
Address	Daigaku-machi 2-7, Takatsuki, Osaka, Japan
TEL	072-683-1221
Email	ane022@osaka-med.ac.jp

Public contact
Name of contact person	Hiroaki Sano
Organization	Osaka Medical College
Division name	Depertment of Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Incidences of postoperative sore throat and hoarseness were significantly lower in the ST9 stimulated group than in the Control group.
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