UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014729 |
|---|---|
| Receipt number | 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 19:42:13 |
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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
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/
miharaxxxtotoro@yahoo.co.jp
Sponsor or person
Institute
Kanagawa children's medical center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017027
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
