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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014729
Receipt No. R000017027
Scientific Title The effect of electrical stimuration using neuromuscular transmission monitor at unilateral HT7 acupoint on preventing emergence agitation in children.
Date of disclosure of the study information 2014/07/31
Last modified on 2016/06/22

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Basic information
Public title The effect of electrical stimuration using
neuromuscular transmission monitor at unilateral HT7 acupoint on preventing emergence agitation in children.
Acronym The effect of electrical stimuration at unilateral HT7 acupoint on preventing emergence agitation in children.
Scientific Title The effect of electrical stimuration using
neuromuscular transmission monitor at unilateral HT7 acupoint on preventing emergence agitation in children.
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Nobuhito Nakamura
Organization Kanagawa children's medical center
Division name Department of Anesthesiology
Zip code
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
1st name
Middle name
Last name Takahiro Mihara
Organization Kanagawa children's medical center
Division name Department of Anesthesiology
Zip code
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

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)

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 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

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
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
2014 Year 07 Month 26 Day
Date of IRB
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

Other
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

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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