臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 02, 2024
Last modified on	Oct. 02, 2024
Trial ID	jRCTs072240066

Scientific Title	Non-randomized trial to evaluate the efficacy and safety of the Nociception Level Index in supine surgery patients (NOL study)
Public Title	NOL study (NOL study)

Contact for Scientific Queries	Name	Yamaura Ken
	Affiliation	Kyushu University Hospital
	Address	3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka 812-8582, Japan
	Telephone	+81-92-642-5714
	E-mail	yamaura.ken.361@m.kyushu-u.ac.jp
Contact for Public Queries	Name	Asada Masako
	Affiliation	Kyushu University Hospital
	Address	3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka 812-8582, Japan
	Telephone	+81-92-642-5714
	E-mail	asada.masako.105@m.kyushu-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 02, 2024
Actual date of first enrollment
Target sample size		110
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1) Participants undergoing posterior spinal fusion surgery (open surgery) 2) Participants who have given their own voluntary written consent (for retrospective study participants, those who can opt out of the study) 3) Participants aged 16 to 79 years at the time of consent 4) Participants weighing 30kg or more 5) Participants with ASA-PS of I to III before the start of the study
	Exclusion Criteria	1) Participants with arrhythmia 2) Participants with a history of drug hypersensitivity (propofol, remifentanil, and/or fentanyl) 3) Participants taking steroids 4) Endoscopic surgery, anterior cervical discectomy and fusion 5) Participants who the principal investigator judges inappropriate for inclusion in the study
	Age Minimum	16age old over
	Age Maximum	79age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Spine
Intervention(s)		Anesthesia management using Nociception level index (NOL)
Health Condition(s) Keyword		Spine
Intervention(s) Keyword		Nociception level index
Health Condition(s) Code		D013131
Intervention(s) Code
Primary Outcome(s)		Intraoperative remifentanil dose
Secondary Outcome(s)		Events during anesthesia 1) Vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine) 2) Hypotension: mean arterial pressure < 55 mmHg (severe hypotension) or mean arterial pressure < 60 mmHg (moderate hypotension) 3) Hypertension: systolic blood pressure > 140 mmHg 4) Bradycardia: heart rate < 45 min-1 5) Tachycardia: heart rate > 90 min-1 Intraoperative information 1) Fentanyl consumption 2) Propofol consumption 3) Stress hormone (cortisol, ACTH) levels (before surgery and at time of leaving operation room) 4) Nociception level index Post-operative information 1) Post-operative pain score (NRS) (24 hours) 2) Total dose of postoperative fentanyl (24 hours) 3) Total dose of postoperative analgesics (NSAIDs, etc.) (24 hours) 4) Serum creatinine and troponin levels (before surgery and after the postoperative day 1)

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	TERUMO CORPORATION
Secondary Sponsor	Applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Kyushu University Certificate Institute Review Board for Clinical Trials
Address	3-1-1, Midashi, Higashi-ku, Fukuoka City, Fukuoka
Telephone	+81-92-642-5082
E-Mail	kyudai-rinri@jimu.kyushu-u.ac.jp
Approval Status	Approval
Date of approval	Aug. 28, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none