UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of electrical stimuration using neuromuscular transmission monitor at unilateral HT7 acupoint on preventing emergence agitation in children.
Title of the study (Brief title)	The effect of electrical stimuration at unilateral HT7 acupoint on preventing emergence agitation in children.
Region	Japan

Condition
Condition	Pediatric patients who are scheduled to undergo surgery under general anesthesia.
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Aim of our study is to evaluate the effect of electrical stimulation using neuromuscular transmitter monitoring device(NTM) to the HT7 acupoint for preventing emergence agitation in pediatric patients by double-blind, randomized controlled study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of emergence agitation under general anesthesia with sevoflurane
Key secondary outcomes	Severity of emergence agitation,recovery time,incidence pf PONV, incidence of other adverce effect, and rescuedrug use for the emergence agitation

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	HT7 stimulation group: We plan to stimulate unilateral(Right side) HT7 acupoint using Neuromuscular transmission monitor(TOF watch). Single-teitch stimulation with 1Hz(over 0.2 ms, at a constant current of 50 mA)was applied for the group throughout operation.
Interventions/Control_2	Control group: The neuromuscular transmission monitor electrode attachments are placced on all subject at Right side HT7 acupoint, but electrical stimulation is not applied.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 months-old <=
Age-upper limit	96 months-old >=
Gender	Male and Female
Key inclusion criteria	ASA 1 or 2 Patients who are scheduled to undergo surgery under general anesthesia with sevoflurane
Key exclusion criteria	Children with developmental delay, psychological or neurological disorders, abnormal airway, use ofpsychiatric or sadative medication or reactive airway disease are excluded.
Target sample size	100

Research contact person
Name of lead principal investigator	Nobuhito Nakamura
Organization	Kanagawa children's medical center
Division name	Department of Anesthesiology
Address	Mutsukawa 2-138-4, Minami-ku, Yokohama Kanagawa, Japan
TEL	045-711-2351
Email	nakanobu@rk9.so-net.ne.jp

Public contact
Name of contact person	Takahiro Mihara
Organization	Kanagawa children's medical center
Division name	Department of Anesthesiology
Address	Mutsukawa 2-138-4, Minami-ku, Yokohama Kanagawa, Japan
TEL	045-711-2351
Homepage URL	http://kanagawa-pho.jp/osirase/byouin/kodomo/
Email	miharaxxxtotoro@yahoo.co.jp

Sponsor
Institute	Kanagawa children's medical center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
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	神奈川県立こども医療センター

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 26 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2015 Year 09 Month 20 Day
Date of closure to data entry	2015 Year 09 Month 20 Day
Date trial data considered complete	2015 Year 09 Month 30 Day
Date analysis concluded	2015 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 31 Day
Last modified on	2016 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017027