UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in children.
Acronym	Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in children.
Scientific Title	Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in children.
Scientific Title:Acronym	Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in children.
Region	Japan

Condition
Condition	peadatric patients undergoing general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigating the Safety and Efficacy of Remimazolam for General Anesthesia in Children
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Drug dosage, additional intraoperative sedatives, time taken from end of administration to awakening, complications (laryngospasm, postoperative nausea and vomiting, delayed awakening)
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	Not applicable
Age-upper limit	15 years-old >
Gender	Male and Female
Key inclusion criteria	Child undergoing general anesthesia with remimazolam administration
Key exclusion criteria	none
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Norifumi Middle name Last name Kuratani
Organization	Saitama Children's Medical Center
Division name	Department of Anesthesiology
Zip code	330-8777
Address	1-2 Shin-toshin, Chuo-ku, Saitama-City Saitama
TEL	048-601-2200
Email	nori-kuratani@umin.ac.jp

Public contact
Name of contact person	1st name Tomoyuki Middle name Last name Miyashita
Organization	Saitama Red Cross Hospital
Division name	Department of Anesthesiology
Zip code	330-8553
Address	1-5 Shin-toshin, Chuo-ku, Saitama-City Saitama
TEL	048-852-1111
Homepage URL
Email	mactak_llp@hotmail.com

Sponsor
Institute	Saitama Children's Medical Center
Institute
Department

Funding Source
Organization	Department of Anesthesiology
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saitama Children's Medical Center
Address	1-2 Shin-toshin, Chuo-ku, Saitama-City Saitama
Tel	048-601-2200
Email	mactak_llp@hotmail.com

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 07 Month 01 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	2020 Year 08 Month 01 Day
Date of IRB	2020 Year 08 Month 01 Day
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We collected information from the electronic anesthesia chart (ORSYS) and the electronic medical record (MegaOak) on drug dosage, additional intraoperative sedation, time from the end of administration to awakening, and complications (laryngospasm, postoperative nausea and vomiting, and delayed awakening) in cases where remimazolam was used for general anesthesia in children. Information on these complications (laryngospasm, postoperative nausea and vomiting, delayed awakening) will be collected from the electronic anesthesia chart (ORSYS) and the electronic medical record (MegaOak).

Management information
Registered date	2021 Year 06 Month 23 Day
Last modified on	2021 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050979