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	jRCT1032260135

Scientific Title	Comparison of hemodynamic changes during anesthetic induction with remimazolam high-flow nasal oxygen therapy and face mask ventilation in patients undergoing cardiovascular surgery
Public Title	Comparison of hemodynamic changes between high-flow nasal oxygen therapy and face mask ventilation during anesthetic induction in cardiovascular surgery

Contact for Scientific Queries	Name	Asai Takashi
	Affiliation	Dokkyo Medical University Saitama Medical Center
	Address	2-1-50, Minamikoshigaya, Koshigaya, Saitama
	Telephone	+81-48-965-4948
	E-mail	asaita@dokkyomed.ac.jp
Contact for Public Queries	Name	Uchida Reo
	Affiliation	Dokkyo Medical University Saitama Medical Center
	Address	2-1-50,Minamikoshigaya,Koshigaya,Saitama
	Telephone	+81-48-965-4948
	E-mail	r-uchida@dokkyomed.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		May. 18, 2026
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients scheduled to undergo cardiovascular surgery under general anesthesia 2. Patients in whom remimazolam is used as the sedative agent for anesthesia induction 3. Patients aged 70 years or older at the time of informed consent 4. Patients with an American Society of Anesthesiologists Physical Status classification of 2 and 3 Class II: Patients with mild to moderate systemic disease Class III: Patients with severe systemic disease 5. Patients who have provided written informed consent to participate in this study
	Exclusion Criteria	1. Patients undergoing emergency surgery 2. Patients who may be pregnant 3. Patients with anticipated difficult airway or difficult intubation 4. Patients with a body mass index (BMI) of 35 or higher (kg / m^2 ) 5. Patients with high risk of aspiration 6. Patients with conditions in which carbon dioxide retention is undesirable (e.g., pulmonary hypertension, right heart failure)
	Age Minimum	70age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients aged 70 years or older scheduled to undergo cardiovascular surgery under general anesthesia
Intervention(s)		High-flow nasal oxygen therapy
Health Condition(s) Keyword		General Anesthesia
Primary Outcome(s)		Incidence of hypotension (defined as a mean arterial pressure < 65 mmHg)
Secondary Outcome(s)		Total dose of vasopressors administered during anesthetic induction Incidence of hypoxemia (defined as a oxygen saturation of < 95%)

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Research ethics committee of dokkyo medical university saitama medical center
Address	2-1-50, Minamikoshigaya, Koshigaya, Saitama, Saitama, Saitama
Telephone	+81-48-965-1111
E-Mail	k-shien@dokkyomed.ac.jp
Approval Status	Approval
Date of approval	Jan. 13, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none