OPTIMIST-h study

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs052230195

Enrollment

Registered

2024-03-08

Start date

2024-03-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

requiring hysterectomy Hysterectomy

Interventions

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 o

Eligibility

Sex/Gender

Female

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Amount of intraoperative remifentanil usage (Total amount of remifentanil divided by the usagetime (min) and ideal body weight (kg) )	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactYuka Sasaki

Nara Medical University Hospital

yukaa0810@naramed-u.ac.jp+81-744-22-3051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026