UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035107 |
|---|---|
| Receipt number | R000040016 |
| Scientific Title | The efficacy of dexmedetomidine-based monitored-anaesthesia care for pediatric gamma knife radiosurgery |
| Date of disclosure of the study information | 2018/12/02 |
| Last modified on | 2021/06/04 16:18:01 |
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Basic information
Public title
The efficacy of dexmedetomidine-based monitored-anaesthesia care for pediatric gamma knife radiosurgery
Acronym
Dexmedetomidine for pediatric gamma knife radio surgery
Scientific Title
The efficacy of dexmedetomidine-based monitored-anaesthesia care for pediatric gamma knife radiosurgery
Scientific Title:Acronym
Dexmedetomidine for pediatric gamma knife radio surgery
Region
| Japan |
Condition
Condition
Brain tumor, arteriovenous malformation
Classification by specialty
| Radiology | Anesthesiology | Neurosurgery |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of dexmedetomidine-based monitored-anesthesia care for pediatric gamma knife radiosurgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Required concentration of dexmedetomidine for pediatric gamma knife raduisurgery
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Pediatric patients under 16 years old
2. Patients managed under dexmedetomidine-based monitored anesthesia care
3. patients with natural airway
Key exclusion criteria
1. Inappropriate patients for further analysis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ozaki |
Organization
Tokyo Women's Medical University
Division name
Anesthesiology
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
moz@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Kotoe |
| Middle name | |
| Last name | Kamata |
Organization
Tokyo Women's Medical University
Division name
Anesthesiology
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
Homepage URL
macaroon@nifty.com
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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
Tokyo Women's Medical University
Address
8-1 Kawada-cho, Shinuku-ku, Tokyo 162-8666, Japan
Tel
03-3353-8111
rinri.bm@twmu.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
https://www.esaic.org/uploads/2020/04/eja-2019-1.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://www.esaic.org/uploads/2020/04/eja-2019-1.pdf
Number of participants that the trial has enrolled
13
Results
Intravenous sedation was commenced with a loading dose of dexmedetomidine (6 mcg/kg for 10 minutes) and boluses of ketamine and fentanyl. Dexmedetomidine infusion rate was subsequently changed between 0.3 and 1.0 mcg/kg/h according to the patient's heart rate. The level of dexmedetomidine plasma concentration was comparable with that used for patients in intensive care, though the required infusion rate was higher than in adult cases (0.2-0.7 mcg/kg/h).
Results date posted
| 2021 | Year | 06 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A consecutive pediatric GKRS managed under dexmedetomidine-based MAC
Participant flow
No problem
Adverse events
None
Outcome measures
Intraoperative dexmedetomidine infusion rate and incidence of perioperative complication were analyzed based on anesthetic charts and surgical dictations. Plasma concentration of dexmedetomidine was calculated by NONMEM 7.3.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 12 | Month | 02 | Day |
Last modified on
| 2021 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040016
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
