臨床研究等提出・公開システム

Scientific Title	Establishment of a method to measure the concentration of protein non-binding remimazolam
Public Title	Measurement of the concentration of free remimazolam

Contact for Scientific Queries	Name	Yoshikawa Yusuke
	Affiliation	Sapporo Medical University
	Address	South1 West17 Chuoku Sapporo
	Telephone	+81-11-688-9663
	E-mail	y.yoshikawa@sapmed.ac.jp
Contact for Public Queries	Name	Yoshikawa Yusuke
	Affiliation	Sapporo Medical University
	Address	South1 West17 Chuoku Sapporo
	Telephone	+81-11-688-9663
	E-mail	y.yoshikawa@sapmed.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 29, 2023
Actual date of first enrollment
Target sample size		5
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Equal to or older than 20 years old Patients who receive cardiovascular surgery under cardiopulmonary bypass with remimazolam
	Exclusion Criteria	Refusal to participate Emergent case Allergy against remimazolam Acute angle closure glaucoma Myasthenia gravis Hepatic failure (Child Pugh equal to or more than 2) Renal failure (sCre equal to or more than 2 mg/dL) Obesity (BMI equal to or more than 35 kg/m2) Deep hypothermic circulatory arrest Patients who are considered to be inappropriate to participate to the study
	Age Minimum	201age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cardiocascular surgery
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Concentration of free remimazolam
Secondary Outcome(s)		Concentration of total remimazolam, a metabolite of remimazolam (CNS7054), and albumin Protein binding ratio of remimazolam

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	The Institutional Review Board of Sapporo Medical University Hospital
Address	South 1, West 16, 291, Chuo-ku, Sapporo, Hokkaido, Hokkaido, Hokkaido
Telephone	+81-11-611-2111
E-Mail	ji-rskk@sapmed.ac.jp
Approval Status	Approval
Date of approval	Mar. 09, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none