UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the effect on the facial edema by acupuncture stimulation
Title of the study (Brief title)	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	Toshiaki Minami
Organization	Osaka Medical College
Division name	Deertment 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	Deertment 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 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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027407