臨床研究等提出・公開システム

Date of registration	April. 08, 2024
Last modified on	Mar. 17, 2026
Trial ID	jRCT1031240017

Scientific Title	A comparison of rocuronium potentiation responses to remimazolam, sevoflurane and propofol in eldery : A prospective comparative study.
Public Title	A comparison of rocuronium potentiation responses to remimazolam, sevoflurane and propofol in eldery : A prospective comparative study.

Completion date	Aug. 31, 2025
Result actual enrolment	48
Adverse events	None
Outcome measures	In the sevoflurane group, the times to reappearance of TOF1 and TOF2 were significantly prolonged compared with the propofol group. In the remimazolam group, the times to reappearance of PTC1 and TOF2 were significantly prolonged compared with the propofol group.
Brief summary	These findings suggest that neuromuscular blockade may be prolonged when remimazolam is used for anesthesia in elderly patients.

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1031240017

Contact for Scientific Queries	Name	Takagi Shunichi
	Affiliation	Nihon University Itabashi Hospital
	Address	tokyo itabashi ooyaguchikamimachi 30-1
	Telephone	+81-3-3972-8111
	E-mail	nakamura.hanae@nihon-u.ac.jp
Contact for Public Queries	Name	Sato Hanae
	Affiliation	Nihon University Itabashi Hospital
	Address	tokyo itabashi ooyaguchikamimachi 30-1
	Telephone	+81-3-3972-8111
	E-mail	nakamura.hanae@nihon-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		April. 08, 2024
Target sample size		48
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 over 65 years 2) Patients with American Society of Anesthesiologists physical status classification 1-3. 3) Patients who receive written informed 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	65age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients undergoing general anesthesia
Intervention(s)		The sedative of choice is remimazolam, sevoflurane, or propofol, depending on the envelope method. Blood samples are drawn during general anesthesia.
Primary Outcome(s)		PTC appearance time in remimazolam, sevoflurane, and propofol groups
Secondary Outcome(s)		T1 and T2 appearance time in sevoflurane, propofol, and remimazolam groups, and time to 100% TOF ratio after sugammadex administration. PTC, and rocuronium-rocuronium protein binding rate in blood at T1 and T2 appearance

Primary Sponsor	Nihon University Itabashi Hospital

Secondary Sponsor

Secondary Sponsor

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	Mar. 26, 2024

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Mar. 17, 2026	(this page)	Changes
2	Mar. 09, 2026	Detail	Changes
1	April. 08, 2024	Detail

List of change history