UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023936 |
|---|---|
| Receipt number | 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 10:23:08 |
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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with a projection,"Kori Spot"(SEIRIN), are attached to the left and right of ST9 after induction of anesthesia, and withdrawn before awakening.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
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
ane095@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
Other
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027208
| 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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