臨床研究等提出・公開システム

Date of registration	June. 01, 2026
Last modified on	July. 21, 2026
Trial ID	jRCT1031260170

Scientific Title	The anti-inflammatory effects of remimazolam on thoracoscopic lobectomy and its impact on cancer cells: A randomized controlled study.
Public Title	The anti-inflammatory effects of remimazolam on thoracoscopic lobectomy and its impact on cancer cells

Contact for Scientific Queries	Name	Itaya Tomoaki
	Affiliation	Nihon University School of Medicine Itabashi Hospital
	Address	30-1 Oyaguchi-Kamicho, Itabashi-ku
	Telephone	+81-3-3972-8111
	E-mail	itaya.tomoaki@nihon-u.ac.jp
Contact for Public Queries	Name	Itaya Tomoaki
	Affiliation	Nihon University School of Medicine Itabashi Hospital
	Address	30-1 Oyaguchi-Kamicho, Itabashi-ku
	Telephone	+81-3-3972-8111
	E-mail	itaya.tomoaki@nihon-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 01, 2026
Target sample size		26
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	1) Patients aged 20 years or older at the time of obtaining consent (pre-operative consultation) 2) Cases with an American Society of Anesthesiologists (ASA) pre-anesthetic risk assessment of 3 or less (ASA classification: 1: No organic, physiological, biochemical, or psychiatric abnormalities. 2: Mild to moderate systemic impairment. 3: Severe systemic impairment. 4: Severe systemic disease that is life-threatening and may not be curable even with surgery. 5: Critically ill.) 3) Patients who have received a thorough explanation at the pre-operative consultation regarding participation in this study, fully understood the information, and provided written consent of their own free will. 4) A patient with a tumor predominantly composed of solid components who is undergoing thoracoscopic lobectomy.
	Exclusion Criteria	1) Patients whose primary cancer is not lung cancer 2) Patients with poorly controlled diabetes (HbA1c > 8.0%) 3) Patients with severe renal impairment (eGFR < 30%) 4) Patients with severe hepatic impairment (Child-Pugh C or higher) 5) Patients taking steroids 6) Patients with inflammatory diseases or symptoms of infection 7) Patients with stage II or higher lung cancer 8) Other patients deemed unsuitable as research subjects by the principal investigator 9) Individuals who have refused to participate in this study
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		This study targets patients undergoing thoracoscopic lobectomy under general anesthesia.
Intervention(s)		Patients will be randomly assigned to receive either the remimazolam group or the sevoflurane group.
Primary Outcome(s)		Changes in inflammatory cytokines in plasma
Secondary Outcome(s)		Proliferative capacity of human lung cancer cells Metastatic and invasive capacity of human lung cancer cells Transformation into chemokines and growth factors

Primary Sponsor	none

Name of Certified Review Board	Nihon University Itabashi Hospital Certified Clinical Research Review Board
Address	30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo
Telephone	+81-3-3972-8111
E-Mail	med.itabashi.clinicalresearch@nihon-u.ac.jp
Approval Status	Approval
Date of approval	May. 26, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
2	July. 21, 2026	(this page)	Changes
1	June. 01, 2026	Detail

List of change history