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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022584
Receipt No. 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 2019/07/23

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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
Institute Hokkaido University Hospital
Institute
Department

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 No longer recruiting
Date of protocol fixation
2011 Year 02 Month 03 Day
Date of IRB
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
2019 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.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


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