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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025691
Receipt No. R000029447
Scientific Title Study on the effect on the facial edema by electronic stimulation at Yifeng(Th17) acupuncture points
Date of disclosure of the study information 2017/01/16
Last modified on 2018/07/24

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Basic information
Public title Study on the effect on the facial edema by electronic stimulation at Yifeng(Th17) acupuncture points
Acronym Effect on the facial edema by Yifeng stimulus
Scientific Title Study on the effect on the facial edema by electronic stimulation at Yifeng(Th17) acupuncture points
Scientific Title:Acronym Effect on the facial edema by Yifeng stimulus
Region
Japan

Condition
Condition Male patients undergoing elective general anesthesia in the head down position
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 After head lower position in the surgery, the facial edema likely to occur due to the influence of gravity. In addition, since the infusion amount is increased by long surgery time, prone to facial edema. When the facial edema occurs, the patient may feel a cosmetically burden. Because the airways become swollen, there is a risk of difficulty in breathing. There is a possibility that the visual impairment due to eye edema occurs. It is said effective that facial edema is reduced by stimulation of Yifeng(TH17), but the mechanism is not clear, it is statistically not been studied. In the present study, we statistically evaluate facial edema is suppressed by the electrical stimulus to TH17.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The head perimeter is measured before and after surgery. The face and reference scale is captured. Then, the face area is compared before and after surgery. Evaluation of eye edema and eyelid edema is evaluated in four stages on the basis of the clinical evaluation criteria of allergic conjunctival disease of Japanese Ophthalmological Society.
Key secondary outcomes We also ask patients about discomfort, vision, and respiratory difficulty.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 In the electrical stimulation group was sterilized in a total of two locations of the left and right Yifenge electrode fixed with tape. Yifeng is located posterior to lobule of ear in depression between the mandible and mastoid process. . Attach the lead of the electrical stimulation device (manufactured by Nippon Medix) to the electrodes, where the muscle in the vicinity starts the power electrode could be confirmed the movement (twitch) to be jerks, fixed the amount of current (40mArms below), the energization continue. Thereafter, the general anesthesia of the usual administration of the muscle relaxant. Except when the repositioning will continue to energization. After completion of surgery, it is pulled out of the finished electrode energization 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
Key inclusion criteria Patients undergoing elective general anesthesia
Key exclusion criteria Patients of emergency surgery,
Advanced obese patients (BMI35 or more),
Pacemaker fitted patients,
and/or Patients of dermatitis and metal allergy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Minami
Organization Osaka Medical College
Division name Deertment 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 Deertment 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
2017 Year 01 Month 16 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
There was a significant difference in head circumference which is an index of head edema.
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
2017 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 17 Day
Last follow-up date
2017 Year 04 Month 11 Day
Date of closure to data entry
2017 Year 04 Month 11 Day
Date trial data considered complete
2017 Year 04 Month 11 Day
Date analysis concluded
2018 Year 07 Month 24 Day

Other
Other related information There was no significant difference such as arousal excitement.

Management information
Registered date
2017 Year 01 Month 16 Day
Last modified on
2018 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029447

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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