UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023937 |
|---|---|
| Receipt number | R000027407 |
| Scientific Title | Study on the effect on the facial edema by acupuncture stimulation |
| Date of disclosure of the study information | 2016/09/06 |
| Last modified on | 2018/10/09 15:47:11 |
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Basic information
Public title
Study on the effect on the facial edema by acupuncture stimulation
Acronym
Effect on the facial edema by hole stimulus
Scientific Title
Study on the effect on the facial edema by acupuncture stimulation
Scientific Title:Acronym
Effect on the facial edema by hole stimulus
Region
| Japan |
Condition
Condition
Patients undergoing elective general anesthesia in the prone position
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the prone position or head lower 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. There are reports of facial edema is reduced by stimulation of LI4 and ST36, 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 LI4 and ST36.
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 four locations of the left and right Hegu hole and Zusanli hole electrode fixed with tape. Hegu hole is first hand, take from the second metacarpal bone between the second metacarpal bone. Foot Sanriana take on the outside of the tibia outer surface in 4 duty under finger down from the patella outer lower edge. 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 and Female
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
40
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
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
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
Patient characteristics were simular.
The difference before and after operation was significantly smaller in the ACP group compared to control group in chin to mndible edge, head circumstance at eye level, and head circumstance at the maxillary level.
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 | 11 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 09 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 10 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 11 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 11 | Day |
Other
Other related information
No significant difference were seen in the secondary outcomes.
Management information
Registered date
| 2016 | Year | 09 | Month | 05 | Day |
Last modified on
| 2018 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027407
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
