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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035107
Receipt No. R000040016
Official scientific title of the study 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 2018/12/02

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Basic information
Official scientific title of the study The efficacy of dexmedetomidine-based monitored-anaesthesia care for pediatric gamma knife radiosurgery
Title of the study (Brief title) 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 Makoto Ozaki
Organization Tokyo Women's Medical University
Division name Department of Anesthesiology
Address 8-1 Kawada-cho, Shinuku-ku, Tokyo 162-8666, Japan
TEL 03-3353-8111
Email moz@twmu.ac.jp

Public contact
Name of contact person Kotoe Kamata
Organization Tokyo Women's Medical University
Division name Department of Anesthesiology
Address 8-1 Kawada-cho, Shinuku-ku, Tokyo 162-8666, Japan
TEL 03-3353-8111
Homepage URL
Email macaroon@nifty.com

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 03 Month 31 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information None

Management information
Registered date
2018 Year 12 Month 02 Day
Last modified on
2018 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040016

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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