臨床研究等提出・公開システム

Date of registration	Oct. 12, 2023
Last modified on	Mar. 27, 2024
Trial ID	jRCT1071230073

Scientific Title	The influence of remimazolam on the reversal of rocuronium-induced neuromuscular blockade with sugammadex
Public Title	The influence of remimazolam on the reversal of rocuronium-induced neuromuscular blockade with sugammadex

Contact for Scientific Queries	Name	Fujimoto Masafumi
	Affiliation	Kumamoto University Hospital
	Address	1-1-1, Honjyo, Cyuoku, Kumamoto-City, Kumamoto, Japan
	Telephone	+81-96-373-5275
	E-mail	mfujimoto.kmm@gmail.com
Contact for Public Queries	Name	Fujimoto Masafumi
	Affiliation	Kumamoto University Hospital
	Address	1-1-1, Honjyo, Cyuoku, Kumamoto-City, Kumamoto, Japan
	Telephone	+81-96-373-5275
	E-mail	mfujimoto.kmm@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 12, 2023
Actual date of first enrollment		Oct. 31, 2023
Target sample size		30
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients over 18 years old scheduled for elective surgery under general anesthesia. All patients were American Society of Anesthesiologists physical status class I or II.
	Exclusion Criteria	Patients under 18 years old, emergency surgery, obesity (BMI 30 kg/m2 and more), with hepatic and renal dysfunction, with neuromuscular disorder, with contraindication to benzodiazepine
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients scheduled for elective surgery under general anesthesia
Intervention(s)		assignment
Primary Outcome(s)		Time from sugamadex administration to TOF ratio 0.90 and more
Secondary Outcome(s)		Time from initial rocuronium administration to TOF count 0, to reappearance of T1 and T2, and total rocuronium dose used during the surgery.

Name of Certified Review Board	Kumamoto University Certified Clinical Research Review Board
Address	1-1-1, Honjyo, Cyuoku, Kumamoto-City, Kumamoto, Japan, Kumamoto
Telephone	+81-96-373-5966
E-Mail	byi-senshin@jimu.kumamoto-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 03, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Mar. 27, 2024	(this page)	Changes
2	Nov. 09, 2023	Detail	Changes
1	Oct. 12, 2023	Detail

List of change history