臨床研究等提出・公開システム

Date of registration	Dec. 15, 2023
Last modified on	Mar. 18, 2026
Trial ID	jRCT1031230514

Scientific Title	A comparative study of neuromuscular relaxant effects of remimazolam anesthesia in young and elderly patients.
Public Title	A comparative study of neuromuscular relaxant effects of remimazolam anesthesia in young and elderly patients.

Completion date	Aug. 31, 2025
Result actual enrolment	40
Adverse events	None
Outcome measures	In the elderly group, the times to reappearance of PTC1, TOF1, and TOF2 were significantly prolonged compared with the young group. However, there were no significant differences in plasma concentrations of rocuronium or remimazolam between the elderly and young groups.
Brief summary	In the elderly group, the times to reappearance of PTC1, TOF1, and TOF2 were significantly prolonged compared with the young group. However, there were no significant differences in plasma concentrations of rocuronium or remimazolam between the elderly and young groups. In elderly patients, the prolonged neuromuscular blocking effect is considered to be due to reduced clearance of rocuronium.

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1031230514

Contact for Scientific Queries	Name	Takagi Shunichi
	Affiliation	Nihon University School of Medicine
	Address	tokyo itabashi ooyaguchikamimachi 30-1
	Telephone	+81-3-3972-8111
	E-mail	takagi.shunichi@nihon-u.ac.jp
Contact for Public Queries	Name	Takagi Shunichi
	Affiliation	Nihon University School of Medicine, Department of Anesthesiology
	Address	tokyo itabashi ooyaguchikamimachi 30-1
	Telephone	+81-3-3972-8111
	E-mail	takagi.shunichi@nihon-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Dec. 15, 2023
Actual date of first enrollment		Dec. 09, 2023
Target sample size		40
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients whose age is between 20 and 45 years old or between 70 and 91 years old 2. Patients with an American Society of Anesthesiologists pre-anesthesia risk rating of 3 or less 3. Patients who have given consent
	Exclusion Criteria	1. Patients with a history of allergy to muscle relaxants or antagonists 2. Patients with severe complications 3. patients with neuromuscular disease 4. Patients taking medications that may affect the effect of muscle relaxation. 5. Patients who are deemed inappropriate as research subjects by the principal investigator 6. Patients who refuse to participate in the study.
	Age Minimum	20age old over
	Age Maximum	91age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients undergoing general anesthesia
Intervention(s)		Use remimazolam as a sedative. Blood samples are drawn during general anesthesia.
Primary Outcome(s)		PTC appearance time in the young and elderly groups
Secondary Outcome(s)		T1 and T2 appearance time Time until TOF ratio reaches 100% after sugammadex administration PTC, blood rocuronium/remimazolam concentration at T1 and T2 appearance, and rocuronium protein binding rate

Primary Sponsor	Nihon University Itabashi Hospital

Source of Monetary Support	Grants-in-Aid for Scientific Research
Secondary Sponsor	Not applicable

Name of Certified Review Board	Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address	Tokyo itabashiku ooyaguchikamimachi 30-1, Tokyo
Telephone	+81-3-3972-8111
E-Mail	med.itabashi.clinicalresearch@nihon-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 14, 2023

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Mar. 18, 2026	(this page)	Changes
3	Mar. 09, 2026	Detail	Changes
2	May. 27, 2024	Detail	Changes
1	Dec. 15, 2023	Detail

List of change history