臨床研究等提出・公開システム

Date of registration	Feb. 20, 2024
Last modified on	Feb. 20, 2024
Trial ID	jRCT1022230059

Scientific Title	Effects of aging and preoperative cognitive function on EEG during Remimazolam anesthesia
Public Title	Effects of aging and cognitive function on EEG during Remimazolam anesthesia

Contact for Scientific Queries	Name	Kinoshita Hirotaka
	Affiliation	Hirosaki University Hospital
	Address	5 Zaifu-cho, Hirosaki, Aomori, 036-8562, Japan
	Telephone	+81-172395113
	E-mail	hirotakak@hirosaki-u.ac.jp
Contact for Public Queries	Name	Kinoshita Hirotaka
	Affiliation	Hirosaki University Hospital
	Address	5 Zaifu-cho, Hirosaki, Aomori, 036-8562, Japan
	Telephone	+81-172395113
	E-mail	hirotakak@hirosaki-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 20, 2024
Target sample size		90
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Non-cardiac surgery patients over 50 years old undergoing general anesthesia with remimazolam at Hirosaki University Hospital
	Exclusion Criteria	Patients with preoperative diagnosis and treatment of neurodegenerative diseases such as dementia and depression Hemodialysis Patients with ASA 4 or higher Patients who refused to participate
	Age Minimum	50age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Non cardiac surgery
Primary Outcome(s)		Effects of age and preoperative cognitive function on EEG frequency and BIS values during general anesthesia with remimazolam
Secondary Outcome(s)		Association between incidence of postoperative delirium and EEG characteristics

Primary Sponsor	Kenichi Hakamada

Source of Monetary Support	Grants-in-Aid from the Japan Society for the Promotion of Science
Secondary Sponsor	Not applicable

Name of Certified Review Board	IRB of Hirosaki Graduate School of Medicine
Address	5 Zaifucho, hirosaki, Aomori, Japan, Aomori
Telephone	+81-172-39-5362
E-Mail	rinri@hirosaki-u.ac.jp
Approval Status	Approval
Date of approval	Jan. 25, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None