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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046080
Receipt No. R000052599
Scientific Title Emergence delirium in children undergoing dental treatment : a comparison of sevoflurane and desflurane
Date of disclosure of the study information 2021/11/16
Last modified on 2021/11/30

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Basic information
Public title Emergence delirium in children undergoing dental treatment : a comparison of sevoflurane and desflurane
Acronym Emergence delirium in children undergoing dental treatment : a comparison of sevoflurane and desflurane
Scientific Title Emergence delirium in children undergoing dental treatment : a comparison of sevoflurane and desflurane
Scientific Title:Acronym Emergence delirium in children undergoing dental treatment : a comparison of sevoflurane and desflurane
Region
Japan

Condition
Condition Children undergoing dental treatment by general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparing the incidence of emergence delirium between sevoflurane and desflurane
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of emergence delirium
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Anesthesia was maintained with sevoflurane
Interventions/Control_2 Anesthesia was maintained with desflurane
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
2 years-old <=
Age-upper limit
6 years-old >=
Gender Male and Female
Key inclusion criteria ASA physical status I or II
Key exclusion criteria Children with ASA physical status 3 or above, asthma, intellectual disabilities, autism spectrum disorder, Attention-deficit/hyperactivity disorder, neurologic or psychological disorders
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Shoichi
Middle name
Last name Honma
Organization Hinode Makomanai Dental Hospital
Division name Department of Dental Anesthesiology and Perioperative Management
Zip code 005-0016
Address Minamimachi 4-6-9, Minami-ku, Sapporo, Hokkaido
TEL 011-584-5848
Email shonma1120@yahoo.co.jp

Public contact
Name of contact person
1st name Shoichi
Middle name
Last name Honma
Organization Hinode Makomanai Dental Hospital
Division name Department of Dental Anesthesiology and Perioperative Management
Zip code 005-0016
Address Minamimachi 4-6-9, Minami-ku, Sapporo, Hokkaido
TEL 011-584-5848
Homepage URL
Email shonma1120@yahoo.co.jp

Sponsor
Institute Department of Dental Anesthesiology and Perioperative Management, Hinode Makomanai Dental 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 Ethics Committee of Medical Corporation Jinyukai
Address Hinode Building 4th floor, S1W4, Chuo-ku, Sapporo, Hokkaido
Tel 011-231-2309
Email hinode-m@hinodeshika.or.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

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 16 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 Open public recruiting
Date of protocol fixation
2021 Year 03 Month 02 Day
Date of IRB
2021 Year 03 Month 08 Day
Anticipated trial start date
2021 Year 11 Month 20 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 16 Day
Last modified on
2021 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052599

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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