臨床研究等提出・公開システム

Date of registration	July. 19, 2023
Last modified on	July. 19, 2023
Trial ID	jRCT1032230242

Scientific Title	A Prospective Observational Study of Relationship between Depth of Anesthesia and Electroencephalogram
Public Title	Depth of Anesthesia and Electroencephalogram

Contact for Scientific Queries	Name	Masaaki Asamoto
	Affiliation	University of Tokyo Hospital
	Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
	Telephone	+81-3-3815-5411
	E-mail	masaaki.asamoto@gmail.com
Contact for Public Queries	Name	Masaaki Asamoto
	Affiliation	University of Tokyo Hospital
	Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
	Telephone	+81-3-3815-5411
	E-mail	masaaki.asamoto@gmail.com

Recruitment status	Recruiting


Anticipated date of first enrollment		July. 19, 2023
Target sample size		200
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients undergoing surgeries
	Exclusion Criteria	(1) Patients undergoing head and neck surgery (2) Patients with a history of central nervous system disease
	Age Minimum	No limit
	Age Maximum	No limit

Health Condition(s) or Problem(s) Studied		Patients undergoing surgeries
Primary Outcome(s)		Relationship between electroencephalogram and anesthesia state

Primary Sponsor	NIHON KOHDEN

Source of Monetary Support / Secondary Sponsor	NIHON KOHDEN
Secondary Sponsor	Not applicable

Name of Certified Review Board	The University of Tokyo, Clinical Research Review Board
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
Telephone	+81-3-5841-0818
E-Mail	ethics@m.u-tokyo.ac.jp
Approval Status	Approval
Date of approval	May. 25, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none