OPTIMIST-h study

JRCT ID: jRCTs052230195

Registered date:08/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: requiring hysterectomy
• Date of first enrollment: 08/03/2024
• Target sample size: 75
• Study type: Interventional

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.

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Female

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Sasaki Yuka
• Source(s) of Monetary Support: Nara Medical University