臨床研究等提出・公開システム

Date of registration	Nov. 19, 2024
Last modified on	Nov. 19, 2024
Trial ID	jRCT1031240496

Scientific Title	Pre-administration of ephedrine and onset time of rocuronium action during induction of general anesthesia in elderly patients
Public Title	Pre-administration of ephedrine and onset time of rocuronium action during induction of general anesthesia in elderly patients

Contact for Scientific Queries	Name	Yamamoto Mai
	Affiliation	Nihon University School of Medicine
	Address	30-1, Oyaguchi Kamicho, Itabashi-Ku, Tokyo, Japan
	Telephone	81-3-3972-8111
	E-mail	yamamoto.mai@nihon-u.ac.jp.
Contact for Public Queries	Name	Yamamoto Mai
	Affiliation	Nihon University School of Medicine
	Address	30-1, Oyaguchi Kamicho, Itabashi-Ku, Tokyo, Japan
	Telephone	81-3-3972-8111
	E-mail	yamamoto.mai@nihon-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 19, 2024
Target sample size		30
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	placebo control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients 80 years of age or older undergoing general anesthesia 2) Patients with an American Society of Anesthesiologists pre-anesthesia risk rating of 3 or less 3) Patients with written consent for participation in this study
	Exclusion Criteria	1) Patients who do not meet the above selection criteria 2) Patients with a history of allergy to muscle relaxants 3) Patients with severe systemic complications (American Society of Anesthesiologists pre-anesthetic risk rating of 4 or higher) 4) Obese patients with a BMI of 30 or greater and patients with a body mass index of less than 18.5 5) Patients with neuromuscular diseases 6) Patients with poorly controlled hypertension 7)Patients on beta blockers 8) Patients with a history of cardiovascular disease 9)Patients with moderate to severe hepatic dysfunction (Child-Pugh classification) 10)Patients with moderate to severe renal insufficiency 11) Patients with hyperthyroidism 12) Patients who have refused to participate in this study.
	Age Minimum	80age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients undergoing general anesthesia
Intervention(s)		Administer ephedrine or fresh food at the same time as induction of general anesthesia
Primary Outcome(s)		Onset time of rocuronium action with and without ephedrine during induction of general anesthesia
Secondary Outcome(s)		Cardiac output before and after induction of anesthesia Blood pressure before and after induction of anesthesia Heart rate before and after induction of anesthesia

Name of Certified Review Board	Nihon University School of Medicine
Address	30-1, Oyaguchi Kamicho, Itabashi-Ku, Tokyo, Japan, Tokyo
Telephone	+81-3-3972-8111
E-Mail	med.itabashi.clinicalresearch@nihon-u.ac.jp
Approval Status	Approval
Date of approval	Sept. 17, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none