NOLDOR study

JRCT ID: jRCTs052220034

Registered date:27/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 27/05/2022
• Target sample size: 54
• Study type: Interventional
• Intervention(s): Use the analgesic protocol with a device not approved in Japan (PMD-200)

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 two groups
2) Changes in NoL values before and after events such as intubation, initiation of insufflation and re positioning in laparoscopic surgery
3) Numerical Rating Scale (NRS) values on the day of surgery (2 hours after surgery), 1, 2, 3, and 7 days after surgery, and 3 months after surgery
4) Perioperative opioid consumption
5) Presence of chronic postsurgical pain

Key inclusion & exclusion criteria

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

Include criteria

1) Male patients undergoing scheduled robot-assisted laparoscopic radical prostatectomy
2) Patients who were classed as American societyof anesthesiologists performance status (ASA-PS)
1-3
3) Patients aged between 20 and 85 years old
4) Patients who have given written consent to participate in the study

Exclude criteria

1) Patients undergoing emergency surgery applied for the day
2) Patients taking beta-blockers, or applying patches for this drug
3) Patients taking oral steroids
4) Patients who cannot secure the measurement site due to a amputation of the finger or lesion on
the nail
5) Patients with inability to give consent
6) Patients who have been judged inappropriate in the study by the investigator or sub-investigator

Related Information

• Primary Sponsor: Tanaka Nobuhiro
• Source(s) of Monetary Support: Nara Medical University,Japan Society for the Promotion of Science(JSPS)