臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 08, 2024
Last modified on	April. 14, 2026
Trial ID	jRCTs052230195

Scientific Title	Effect of Opioid Titration protocol using nociception monitors in gynecologic laparoscopic surgery with total hysterectomy: a Randomized Controlled Trial (OPTIMIST-h study)
Public Title	OPTIMIST-h study (OPTIMIST-h study)

Contact for Scientific Queries	Name	Sasaki Yuka
	Affiliation	Nara Medical University Hospital
	Address	840 Shijo-Cho, Kashihara, Nara
	Telephone	+81-744-22-3051
	E-mail	yukaa0810@naramed-u.ac.jp
Contact for Public Queries	Name	Sasaki Yuka
	Affiliation	Nara Medical University Hospital
	Address	840 Shijo-Cho, Kashihara, Nara
	Telephone	+81-744-22-3051
	E-mail	yukaa0810@naramed-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 08, 2024
Actual date of first enrollment		Mar. 25, 2024
Target sample size		75
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Female patients undergoing laparoscopic or robotic-assisted laparoscopic total hysterectomy 2) Patients classified as American Society of Anesthesiologists physical status 1-2 3) Patients between the ages of 20 and 85 years 4) Patients who have given written consent to participate in the study
	Exclusion Criteria	1) Patients who are scheduled to undergo emergency surgery 2) Patients who are being treated with a beta-blocker (oral intake or patch) 3) Patients being treated with steroids 4) Patients who cannot secure the measurement site due to amputated fingers or nail lesions 5) Patients with a pacemaker 6) Patients after heart transplantation 7) Patients using drugs that affect sinus node (atropine, anticholinergic drugs) (8) Patients who are incapable of consenting 9) Patients who are judged to be inappropriate as research subjects by the investigators responsible for the study.
	Age Minimum	20age old over
	Age Maximum	85age old not
	Gender	Female
Health Condition(s) or Problem(s) Studied		requiring hysterectomy
Intervention(s)		Intervention 1) The management protocol based on the Nociception Level (NoL) index calculated using PMD-200 (not approved in Japan) and the BIS monitor. Intervention 2) The management protocol based on HFVI and PSI.
Health Condition(s) Keyword		Hysterectomy
Health Condition(s) Code		Hysterectomy
Primary Outcome(s)		Amount of intraoperative remifentanil usage (Total amount of remifentanil divided by the usagetime (min) and ideal body weight (kg) )
Secondary Outcome(s)		1) Comparison of biomarker values (IL-6, CRP, cortisol) between the three groups 2) Total amount of remifentanil administered during surgery 3) Change in Quality of Recovery Score-15 values on the day before surgery(Pre), postoperative day (POD) 1 and 2. 4) NRS (Numerical Rating Scale) values on the day of surgery (2 hours postoperatively), at POD1, 2, 3 , and at 3 months after surgery 5) Perioperative opioid (fentanyl) consumption 6) Presence of chronic postsurgical pain

Source of Monetary Support	Nara Medical University

Name of Certified Review Board	Nara Medical University Certified Review Board
Address	840 Shijo-cho Kashihara-shi, Nara
Telephone	+81-744-29-8835
E-Mail	ethics_nara@naramed-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 26, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	April. 14, 2026	(this page)	Changes
3	July. 24, 2025	Detail	Changes
2	Jan. 30, 2025	Detail	Changes
1	Mar. 08, 2024	Detail

List of change history