臨床研究等提出・公開システム

Date of registration	Mar. 14, 2023
Last modified on	Sept. 04, 2024
Trial ID	jRCT1051220191

Scientific Title	Investigation of anesthetic fade of motor evoked potentials under remimazolam anesthesia in spinal cord surgery (Anesthetic fade of MEP under remimazolam)
Public Title	Anesthetic fade of MEP under remimazolam

Contact for Scientific Queries	Name	Hayashi Hironobu
	Affiliation	Nara Medical University
	Address	840 Shijo-cho, Kashihara, Nara, Japan
	Telephone	+81-744-22-3051
	E-mail	payashi77@hotmail.com
Contact for Public Queries	Name	Hayashi Hironobu
	Affiliation	Nara Medical University
	Address	840 Shijo-cho, Kashihara, Nara, Japan
	Telephone	+81-744-22-3051
	E-mail	payashi77@hotmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 14, 2023
Target sample size		81
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patients from 12years old to 85 years old, Spine surgery under general anesthesia, Anesthetic duration >4 hours, Measurement of motor evoked potential and train-of-four ratio
	Exclusion Criteria	Cardiac pacemaker, History of epilepsy, Regularly use benzodiazepines, Regular use of antiepileptic drugs
	Age Minimum	12age old over
	Age Maximum	85age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Spine disease
Health Condition(s) Code		D019636
Primary Outcome(s)		Percentage change in amplitude of motor evoked potentials recorded from the abductor pollicis brevis muscle at 4 hours after the start of remimazolam anesthesia.

Primary Sponsor	Mundipharma

Name of Certified Review Board	Nara Medical University Clinical Research Review Board
Address	840 Shijo-cho, Kashihara, Nara, Japan, Nara
Telephone	+81-744-29-8835
E-Mail	ethics_nara@naramed-u.ac.jp
Date of approval	April. 28, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Sept. 04, 2024	(this page)	Changes
1	Mar. 14, 2023	Detail

List of change history