臨床研究等提出・公開システム

Japanese

Date of registration	June. 27, 2024
Last modified on	June. 27, 2024
Trial ID	jRCT1031240189

Scientific Title	Effect of remimazolam on autonomic circulatory control function: a randomized controlled trial
Public Title	Effect of remimazolam on autonomic circulatory control function

Contact for Scientific Queries	Name	Sato Hanae
	Affiliation	Nihon University School of Medicine
	Address	30-1 Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
	Telephone	+81-3-3972-8111
	E-mail	nakamura.hanae@nihon-u.ac.jp
Contact for Public Queries	Name	Sato Hanae
	Affiliation	Nihon University School of Medicine
	Address	30-1 Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
	Telephone	+81-3-3972-8111
	E-mail	nakamura.hanae@nihon-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 27, 2024
Actual date of first enrollment
Target sample size		40
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) Persons who are between 18 and 65 years old at the time of obtaining consent (pre-operative examination) 2) Cases with American Society of Anesthesiologists pre-anesthesia risk assessment 2 or lower (ASA classification 1: No organic, physiological, biochemical or mental abnormality. 2: Mild to moderate systematic disorder. 3: Severe systematic disorder. 4: Severe systematic disease that is threatening life and cannot be cured even with surgery.) 3) Subjects who have received sufficient explanation at the pre-operative examination to participate in this study, and who have given their voluntary written informed consent with full understanding.
	Exclusion Criteria	1)Patients with autonomic nerve imbalance 2)Patients with hypertension 3) Cases with moderate to severe systemic complications (American Society of Anesthesiologists preanesthesia risk assessment 3 or higher) 4)Poorly controlled diabetic patients 5) Patients taking oral medications that affect the autonomic nervous system 6)Other persons who are judged by the research director to be inappropriate as research subjects. 7) Persons who have requested refusal to participate in this research
	Age Minimum	20age old over
	Age Maximum	65age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Diseases that require general anesthesia in the operating room
Intervention(s)		Assign anesthesia maintenance to propofol group and remimazolam group. In the propofol group, propofol 2-2.5 mg/kg was administered intravenously, and in the remimazolam group, remimazolam 12 mg/kg/hour was administered intravenously to induce sleep. Anesthesia maintenance should be 4-10 mg/kg/h in the propofol group and 1-2 mg/kg/h in the remimazolam group.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Spontaneous fluctuation waveforms of heart rate and blood pressure obtained from electrocardiogram and arterial pressure waveforms
Secondary Outcome(s)		Heart rate, blood pressure, cardiac output, respiratory rate, end-tidal carbon dioxide concentration, percutaneous arterial oxygen saturation, BIS value

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Nihon University School of Medicine clinical research ethics committee
Address	30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Tokyo
Telephone	+81-3-3972-8111
E-Mail	med.itabashi.clinicalresearch@nihon-u.ac.jp
Approval Status	Approval
Date of approval	May. 23, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none