臨床研究等提出・公開システム

Date of registration	July. 12, 2024
Last modified on	Nov. 06, 2024
Trial ID	jRCT1030240216

Scientific Title	A study of effectiveness of Remimazolam in Modified Electroconvulsive Therapy
Public Title	A study of effectiveness of Remimazolam in Modified Electroconvulsive Therapy

Contact for Scientific Queries	Name	Shimono Shinako
	Affiliation	SHOWA University Northern Yokohama Hospital
	Address	35-1, Chigasaki-Chuo, Tsuzuki, Yokohama, Kanagawa, Japan
	Telephone	+81-45-949-7000
	E-mail	v4nako@dent.showa-u.ac.jp
Contact for Public Queries	Name	Shimono Shinako
	Affiliation	SHOWA University Northern Yokohama Hospital
	Address	35-1, Chigasaki-Chuo, Tsuzuki, Yokohama, Kanagawa, Japan
	Telephone	+81-45-949-7000
	E-mail	v4nako@dent.showa-u.ac.jp

Recruitment status	Pending


Anticipated date of first enrollment		July. 12, 2024
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1)Patients admitted to the Mental Care Center Ward of Showa University Northern Yokohama Hospital and undergoing mECT 2)Patients with ASA-PS2 and 3 3)Persons who have obtained written consent to participate in this study from the individual or a surrogate 4)Those who are judged to be eligible for participation in this study by the physician in charge of the study, etc. in the pre-test specified in the protocol of this study
	Exclusion Criteria	1) Patients with intracranial hypertension, cerebral aneurysm, recent myocardial infarction (within 3 months), angina pectoris, congestive heart failure 2) Patients with bronchial asthma 3) Patients with neuromuscular disease 4) Patients with a history of hypersensitivity to remimazolam besilate, propofol itself or its components, acute angle closure glaucoma, myasthenia gravis, shock, coma, or acute alcohol intoxication with suppressed vital signs 5) Patients within 3 months of participation in other clinical research 6) Other patients who are judged by the investigator to be ineligible for this study.
	Age Minimum	No limit
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		Drug-resistant depression Schizophrenia
Intervention(s)		Patients will be randomly assigned to remimazolam besilate or propofol groups, each receiving the two drugs at the time of mECT treatment. Delirium will be assessed with the 4AT-J before and after treatment.
Health Condition(s) Code		Depression: D003863 Schizophrenia: D012559
Primary Outcome(s)		4AT-J(Immediately after surgery)
Secondary Outcome(s)		Induction time, hemodynamic changes, seizure duration, recovery time, incidence of vomiting reflex, cough, and tears during anesthesia induction 4AT-J (morning of treatment day, 1 hour after treatment, 3 hours after treatment, morning of next day after treatment)

Primary Sponsor	none

Name of Certified Review Board	Showa University Research Ethics Review Board
Address	1-5-8, Hatanodai, Shinagawa, Tokyo 1428555 JAPAN, Tokyo, Tokyo
Telephone	+81-3-3784-8129
E-Mail	m-rinri@ofc.showa-u.ac.jp
Approval Status	Approval

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Nov. 06, 2024	(this page)	Changes
1	July. 12, 2024	Detail

List of change history