UMIN-CTR Clinical Trial

Basic information
Public title	Electroencephalogramic changes during remimazolam general anesthesia: the relationship between estimated effect-site concentrations and the characteristics of electroencephalogramic changes at unconscious and conscious states
Acronym	Electroencephalogramic changes during remimazolam general anesthesia
Scientific Title	Electroencephalogramic changes during remimazolam general anesthesia: the relationship between estimated effect-site concentrations and the characteristics of electroencephalogramic changes at unconscious and conscious states
Scientific Title:Acronym	Electroencephalogramic changes during remimazolam general anesthesia
Region	Japan

Condition
Condition	Of patients who are undergoing elective breast surgery, participants are included if they have both of the following: 1) American Society of Anesthesiologist (ASA) physical status (PS) classification 1 or 2 2) Capability of providing written consent before participation to this study
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In the course of induction and maintenance of general anesthesia using remimazolam, frontal electroencephalograms (EEGs) during induction (from the start of remimazolam administration to loss of consciousness), maintenance (from the beginning of operations to 10 minutes after), and emergence (from the end of remimazolam administration to recovery of consciousness) phases will be analyzed in order to investigate the relationship between estimated effect-site remimazolam concentrations and the EEG changes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	The relationship between estimated effect-site remimazolam concentrations, and frontal EEG changes during general anesthetic induction, maintenance , and emergence phases, respectively.
Key secondary outcomes	The relationship between estimated effect-site remimazolam concentrations, and Patient State Index (PSI) and Bispectral Index (BIS) during induction , maintenance , and emergence phases, respectively. The trend in EEG frequency change depending on age. The relationship between age and the time from the end of remimazolam administration to recovery of consciousness.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Of patients who are undergoing elective breast surgery, participants are included if they have both of the following: 1) American Society of Anesthesiologist (ASA) physical status (PS) classification 1 or 2 2) Capability of providing written consent before participation to this study
Key exclusion criteria	Participants are excluded if they have any of the following: 1) Contraindications listed on the package insert of remimazolam (hypersensitivity to any of the components of remimazolam, acute closed angle glaucoma, myasthenia gravis, shock, coma, or acute alcoholic poisoning accompanying suppressed vital signs) 2) Contraindication to benzodiazepine 3) History of long-term administration of benzodiazepine 4) Contraindication to fentanyl, remifentanyl, or rocuronium 5) Severe liver dysfunction, renal dysfunction, or heart disease that may affect the safety assessment of remimazolam 6) ASA PS>=3 7) Others that the investigators consider to be inappropriate for a participant of the study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Masui
Organization	Facility of Medicine, Showa University
Division name	Department of Anesthesiology
Zip code	142-8666
Address	1-5-8 Hatanodai, Shinagawa, Tokyo
TEL	03-3784-8575
Email	kmasui@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Maiko Middle name Last name Hosokawa
Organization	Facility of Medicine, Showa University
Division name	Department of Anesthesiology
Zip code	142-8666
Address	1-5-8 Hatanodai, Shinagawa, Tokyo
TEL	03-3784-8575
Homepage URL
Email	maikohskw@med.showa-u.ac.jp

Sponsor
Institute	Showa University Department of Anesthesiology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Human Research Committee at Showa University Facility of Medicine
Address	1-5-8 Hatanodai, Shinagawa, Tokyo
Tel	03-3784-8129
Email	m-rinri@ofc.showa-u.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	昭和大学病院

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 05 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	Preinitiation
Date of protocol fixation	2020 Year 02 Month 25 Day
Date of IRB	2020 Year 04 Month 14 Day
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2022 Year 03 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	2020 Year 06 Month 01 Day
Last modified on	2020 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046238

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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