臨床研究等提出・公開システム

Date of registration	July. 26, 2022
Last modified on	May. 12, 2026
Trial ID	jRCT1051220068

Scientific Title	A randomized controlled trial of the effect of remimazolam on postoperative QT interval in gynecologic laparotomy
Public Title	A clinical trial of the effect of remimazolam on postoperative ECG in gynecologic laparotomy

Contact for Scientific Queries	Name	Hori Kotaro
	Affiliation	Osaka Metropolitan Universtiy Hospital
	Address	Asahimachi 1-5-7, Abenoku, Osaka
	Telephone	+81-666452121
	E-mail	k.hori@omu.ac.jp
Contact for Public Queries	Name	Hori Kotaro
	Affiliation	Osaka Metropolitan University Graduate School of Medicine
	Address	Asahimachi 1-5-7, Abenoku, Osaka
	Telephone	+81-666452186
	E-mail	k.hori@omu.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		July. 26, 2022
Actual date of first enrollment		Sept. 06, 2022
Target sample size		120
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients scheduled for genecologic laparatomy under general anesthesia 2) Patients aged 20 or older 3) Patients classified as ASA-PS 1 or 2 (American Society of Anesthesiologists-Physical Status) 4) Patients who fully understand the study after sufficient explanations and provide the written volun tary consent
	Exclusion Criteria	1) Patients who have contraindication or allergy to sevoflurane or remimazolam 2) Patients who have abnormal QT interval in preoperative ECG 3) Patients who do not have sinus rhythm in preoperative ECG 4) Patients who take antipsychotics, antiarrhythmics, or beta-blockers 5) Patients who have hypokalemia (< 3.5 mEq/L) or hyperkalemia (> 5.5 mEq/L) in preoperative labor atory data 6) Patients whose BMI are 35 or greater 7) Patient who are considered ineligible for enrolling the study by a principal- or co-investigator
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Patients scheduled for gynecologic laparotomy
Intervention(s)		In remimazolam group, remiazolam administration is initiated at 12 mg/kg/h until patients lose their consciousness, and then is decreased at 1 mg/kg/h. The maintenace dose is at the discretion of attending anesthesiologists by using BIS (bispectral index). In sevoflurane group, anesthesia induction is performed with 2 mg/kg propofol bolus. The maintenace dose of sevoflurane is at the discretion of attending anesthesiologists by using BIS.
Primary Outcome(s)		Heart-rate corrected QT (QTc) interval after tracheal extubation
Secondary Outcome(s)		1) Correlation between plasma concentration of remimazolam and QTc 2) Correlation between plasma concentration of ropivacaine and QTc 3) QTc interval during induction of anesthesia 4) Hourly QTc inteval from the beggining to the end of surgery 5) QTc interval at postoperative day 1 6) Incidecne of perioperative fatal arrhythmia through medical record review

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Osaka Metropolitan University Hospital Certified Review Board
Address	6F Abeno Medix, 1-2-7 Asahimachi, Abeno-ku, Osaka 545-0051, Osaka
Telephone	+81-6-6645-3456
E-Mail	gr-a-knky-crb@omu.ac.jp
Approval Status	Approval
Date of approval	June. 29, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	May. 12, 2026	(this page)	Changes
4	Mar. 09, 2026	Detail	Changes
3	Sept. 29, 2023	Detail	Changes
2	Sept. 27, 2023	Detail	Changes
1	July. 26, 2022	Detail

List of change history