臨床研究等提出・公開システム

Scientific Title	Effectiveness of Short-Duration Prewarming Using a Conductive Polymer Warming Device in Patients Undergoing General Anesthesia: A Randomized Controlled Trial (BriefWarming)
Public Title	A Study on the Effect of Brief Prewarming in Patients Undergoing General Anesthesia

Contact for Scientific Queries	Name	Hara Kentaro
	Affiliation	Department of Fundamental Nursing, Faculty of Life Sciences, Kumamoto University
	Address	4-24-1 Kuhonji, Chuo-ku, Kumamoto-shi
	Telephone	+81-90-7581-8662
	E-mail	kentaro-hara@kumamoto-u.ac.jp
Contact for Public Queries	Name	Ishibashi Ayano
	Affiliation	Clinical Research Center, NHO Nagasaki Medical Center, Nagasaki
	Address	2-1001-1, Kubara, Omura
	Telephone	+81-957523121
	E-mail	ishibashi.ayano.uk@mail.hosp.go.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 14, 2023
Actual date of first enrollment		Dec. 14, 2023
Target sample size		82
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Adults aged 20 years over Scheduled for elective laparoscopic lower gastrointestinal surgery ASAPS I to III Undergoing general anesthesia at our institution Able to provide written informed consent
	Exclusion Criteria	Patients under 20 years of age Patients scheduled for emergency surgery Patients with a personal or family history of malignant hyperthermia
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Perioperative Hypothermia
Intervention(s)		Upper and lower limb pre-warming with a 5-minute heating device (intervention group) versus no pre-warming (control group)
Health Condition(s) Keyword		Hypothermia, general anesthesia, warming device, perioperative temperature management
Intervention(s) Keyword		Prewarming, Conductive warming device, Conductive polymer, Temperature management, General anesthesia
Health Condition(s) Code		D006981
Intervention(s) Code		D006736, D001831
Primary Outcome(s)		Core body temperature
Secondary Outcome(s)		Core temperature change before and 30 min after introduction Time-series changes in peripheral temperature and PI

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Ethics Review Committee, NHO Nagasaki Medical Center
Address	2-1001-1, Kubara, Omura, Nagasaki
Telephone	+81-957523121
E-Mail	611-kenkyu@mail.hosp.go.jp
Approval Status	Approval
Date of approval	Dec. 14, 2023

Plan to share IPD	No

Secondary ID(s)	UMIN000053127
Issuing Authority	UMIN

Countries of Recruitment（Except Japan）	none