UMIN-CTR Clinical Trial

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
Email	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
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)

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040016