臨床研究等提出・公開システム

Date of registration	May. 18, 2026
Last modified on	May. 18, 2026
Trial ID	jRCT1052260053

Scientific Title	The effects of remimazolam and sevoflurane on hemodynamics during Endovascular Aneurysm Repair under general anesthesia: A randomized controlled trial
Public Title	The effects of anesthetics on hemodynamics during EVAR: RCT

Contact for Scientific Queries	Name	Toshikazu Okita
	Affiliation	Nara Prefecture General Medical Center
	Address	897-5 2-chome, Shichijo Nishimachi, Nara-shi, Nara, Japan
	Telephone	+81-742466001
	E-mail	toratora424@gmail.com
Contact for Public Queries	Name	Toshikazu Okita
	Affiliation	Nara Prefecture General Medical Center
	Address	897-5 2-chome, Shichijo Nishimachi, Nara-shi, Nara, Japan
	Telephone	+81-742466001
	E-mail	toratora424@gmail.com

Recruitment status	Complete

Anticipated date of first enrollment		Nov. 30, 2022
Actual date of first enrollment		Nov. 30, 2022
Target sample size		31
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	31 patients with abdominal aortic aneurysms undergoing EVAR (Endovascular Aneurysm Repair) under general anesthesia
	Exclusion Criteria	(1) Patients who are in atrial fibrillation at the time of admission to the operating room and cannot be evaluated for appropriate heart rate variability (2) Dialysis patients (3) Patients taking benzodiazepine medications (4) Patients for whom Anelem is contraindicated (5) Patients for whom sevoflurane is contraindicated
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Abdominal Aortic Aneurysm
Intervention(s)		Randomization will be conducted to evaluate the use of remimazolam or sevoflurane as an anesthetic maintenance agent.
Primary Outcome(s)		AUT (Area Under Threshold), which combines the duration and magnitude of periods when the average blood pressure is below 65 mmHg
Secondary Outcome(s)		Number of episodes of hypotension Total duration of hypotension Occurrence of severe hypotension (mean arterial pressure < 50 mmHg) Amount of vasopressor used during surgery

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Nara Prefecture General Medical Center Ethics Committee
Address	897-5 2-chome, Shichijo Nishimachi, Nara-shi, Nara, Japan, Nara
Telephone	+81-742466001
E-Mail	so-rin@nara-hp.jp
Approval Status	Approval
Date of approval	Oct. 20, 2022

Plan to share IPD	Yes
Plan description	The data will be anonymized; however, limited re-identification may be possible from the combination of surgery date, age, and sex.

Countries of Recruitment（Except Japan）	none