UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022584
Receipt number R000024415
Scientific Title A Study of general anesthesia management method in patients with autistic spectrum disorders
Date of disclosure of the study information 2016/06/02
Last modified on 2023/01/04 18:35:48

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A Study of general anesthesia management method in patients with autistic spectrum disorders

Acronym

A Study of general anesthesia management method in patients with autistic spectrum disorders

Scientific Title

A Study of general anesthesia management method in patients with autistic spectrum disorders

Scientific Title:Acronym

A Study of general anesthesia management method in patients with autistic spectrum disorders

Region

Japan


Condition

Condition

Autistic spectrum disorder

Classification by specialty

Anesthesiology Dental medicine Adult
Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the effectiveness of "structured teaching methods", which is used for education of autism spectrum disorder, to avoid physical restraint and to same a safe and smooth induction of general anesthesia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Whether physical restraint was needed or not during induction of anesthesia after rehearsal and training for the induction of anesthesia: the comparison with past cases

Key secondary outcomes

1) Comparison of the cooperation before and after rehearsal and training of the anesthesia induction.
2) Evaluation of stress for anesthesia induction: Comparison of degree of the stress between anesthesia induction and venipuncture to take blood samples using analysis of hormone such as epinephrine, norepinephrinedopamine, cortisol and ACTH.
3) Relevance of the items which can grasp preoperatively and the presence and the degree of physical restraint
4) The comparison of the degree of physical restraint between the rehearsal for the induction of anesthesia and the induction of anesthesia of the day.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

1) Preoperative consultation day:
1. A rehearsal for induction of anesthesia
The patients are shown picture cards, which consist of a series of pictures of the places, tools and processes that the patient will see and experience during the induction of anesthesia.
Then we take them to the treatment room presenting the picture cards.
We try to attach monitors such as pulse oximeter, ECG seal and manchette and finally, conclude the rehearsal by putting and holding a facemask.
2. Blood sampling for measuring stress hormone
We take blood samples more than about 4cc to measure stress hormone such as epinephrine, norepinephrine, dopamine, cortisol and ACTH.
2) Training at home and facilities for induction of anesthesia:
We lend the picture cards and facemask to the patient's guardians, and ask them to practice the procedure repeatedly with them at home or at their care facility from preoperative consultation day to operative day.
3) The operative day:
1. We try to give anesthesia in the same way as rehearsal and training for induction of anesthesia consultation day.
2. Blood sampling for measuring stress hormone same kinds as preoperative consultation day.

Interventions/Control_2


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

5 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with autism spectrum disorder who is scheduled to undergo dental treatment under general anesthesia at the Outpatient Clinic of the Department of Dental Anesthesiology of Hokkaido University Hospital.

Key exclusion criteria

1) Patients whose communication ability is completely lacked.
2) Patients less than 5 years old

Target sample size

55


Research contact person

Name of lead principal investigator

1st name Makiko
Middle name
Last name Shibuya

Organization

Graduate School of Dental Medicine, Hokkaido University

Division name

Department of Dental Anesthesiology

Zip code

0608586

Address

KIta-13 Nishi-7 Kita-ku Sapporo, 060-8586, JAPAN

TEL

+81-11-706-4336

Email

shibu@den.hokudai.ac.jp


Public contact

Name of contact person

1st name Makiko
Middle name
Last name Shibuya

Organization

Graduate School of Dental Medicine, Hokkaido University

Division name

Department of Dental Anesthesiology

Zip code

0608586

Address

KIta-13 Nishi-7 Kita-ku Sapporo, 060-8586, JAPAN

TEL

+81-11-706-4336

Homepage URL


Email

shibu@den.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Hospital

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

Institutional Review Board of Hokkaido University Hospital

Address

North 14, West 5, Kita-ku, Sapporo

Tel

011-706-7636

Email

crjimu@huhp.hokudai.ac.jp


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

北海道大学病院(北海道)/Hokkaido University Hospital(Hokkaido)


Other administrative information

Date of disclosure of the study information

2016 Year 06 Month 02 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

2011 Year 02 Month 03 Day

Date of IRB

2013 Year 06 Month 10 Day

Anticipated trial start date

2011 Year 08 Month 08 Day

Last follow-up date

2016 Year 07 Month 31 Day

Date of closure to data entry

2017 Year 09 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 02 Day

Last modified on

2023 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024415


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name