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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044630
Receipt No. R000050979
Scientific Title Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in children.
Date of disclosure of the study information 2021/07/01
Last modified on 2021/06/23

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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

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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