臨床研究等提出・公開システム

Date of registration	Oct. 18, 2021
Last modified on	Oct. 18, 2021
Trial ID	jRCT1011210042

Scientific Title	Influence of sevoflurane and propofol on intraoperative neuromonitering during thyroidectomy
Public Title	Influence of anesthesia on intraoperative neuromonitering during thyroidectomy

Contact for Scientific Queries	Name	Chaki Tomohiro
	Affiliation	Sapporo Medical University School of Medicine Hospital
	Address	291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
	Telephone	+81-11-611-2111
	E-mail	chakitomohiro0728@yahoo.co.jp
Contact for Public Queries	Name	Chaki Tomohiro
	Affiliation	Sapporo Medical University School of Medicine Hospital
	Address	291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
	Telephone	+81-11-611-2111
	E-mail	chakitomohiro0728@yahoo.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 18, 2021
Target sample size		36
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who undergo thyroidectomy using intraoperative neuromonitering with NIM system under general anesthesia
	Exclusion Criteria	Patients who have any abnormalities which influence intraoperative neuromonitering such as reccurent nerve palsy Patients who have neuromuscular disease
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Thyroid neoplasm
Intervention(s)		General anesthesia is maintained using sevofluran or propofol according to randomization.
Health Condition(s) Keyword		Thyroid tumor
Health Condition(s) Code		D013964
Primary Outcome(s)		Positive rate of first nerve stimulation
Secondary Outcome(s)		Time from administration of muscle relaxation to first positive nerve reaction Latency and amplitude of detected wave Rate of postoperative reccurent nerve palsy (just after operation, 1 week after operation)

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Institutional review board of Sapporo Medical University School of Medicine Hospital
Address	291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido
Telephone	+81-11-611-2111
E-Mail	ji-rskk@sapmed.ac.jp
Approval Status	Approval
Date of approval	Sept. 27, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none