UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046080 |
|---|---|
| Receipt number | 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 | 2024/11/18 10:43:55 |
* 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
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
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
shonma1120@yahoo.co.jp
Sponsor or person
Institute
Department of Dental Anesthesiology and Perioperative Management, Hinode Makomanai Dental 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
Ethics Committee of Medical Corporation Jinyukai
Address
Hinode Building 4th floor, S1W4, Chuo-ku, Sapporo, Hokkaido
Tel
011-231-2309
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
Completed
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
| 2024 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052599
