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 |
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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
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
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
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
