UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000011704
Receipt number	R000013560
Scientific Title	The effect of electrical stimulation generated by neuromuscular transmission monitor to the HT7 acupuncture point on preventing emergence agitation in children. A prospective double-blind randomized controlled trial.
Date of disclosure of the study information	2013/09/14
Last modified on	2014/03/12 21:15:31

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Basic information

Public title

The effect of electrical stimulation generated by neuromuscular transmission monitor to the HT7 acupuncture point on preventing emergence agitation in children. A prospective double-blind randomized controlled trial.

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Pediatric patients who are scheduled to undergo surgery under general anesthesia.

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

Our aim is to detect the effect of electrical stimulation using neuromuscular transmitter monitoring device (NTM) to the heart 7 (HT7) acupoint for preventing emergence agitation in pediatric patients in this prospective, 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 in children

Key secondary outcomes

rescue drug use for the emergence agitation, rescue drug use for the postoperative pain, severity of the agitation, and severity of the pain

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

HT7 stimulation group:
we plan to stimulate both right and left sides of HT7 acupuncture site using neuromuscular transmission monitor (TOFwatch). Single-twitch stimulation with 1 Hz (over 0,2 ms, at a constant current of 50 mA) was applied for the group throughout operation.

Interventions/Control_2

Control group:
The NTM electrode attachments are placed on all subject at both left and right hand of HT7 acupuncture site, 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, or reactive airway disease, are excluded

Target sample size

130

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Toshiyuki Hijikata

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

th.1984.06.01@gmail.com

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 or person

Institute

Kanagawa children's medical center

Institute

Department

Personal name

Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Kanagawa children's medical center

Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 14 Day

Related information

URL releasing protocol

http://kanagawa-pho.jp/osirase/byouin/kodomo/

Publication of results

Partially published

Result

URL related to results and publications

http://kanagawa-pho.jp/osirase/byouin/kodomo/

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

2013 Year 09 Month 05 Day

Date of IRB

Anticipated trial start date

2013 Year 09 Month 10 Day

Last follow-up date

2014 Year 03 Month 10 Day

Date of closure to data entry

Date trial data considered complete

2013 Year 03 Month 31 Day

Date analysis concluded

2013 Year 03 Month 31 Day

Other

Other related information

Management information

Registered date

2013 Year 09 Month 11 Day

Last modified on

2014 Year 03 Month 12 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013560