Physician-led clinical trial for the development of PMS-2, a device to objectively monitor the efficacy of analgesic drugs for postoperative pain

JRCT ID: jRCT1052230029

Registered date:28/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients scheduled to undergo surgery under general anesthesia
• Date of first enrollment: 06/03/2024
• Target sample size: 30
• Study type: Observational

Outcome(s)

• Primary Outcome: Amount of change in PS calculated by PMS-2 over time

Secondary Outcome

(1) Rate of change in PS calculated by PMS-2 over time
(2) Correlation between the amount of change in PS calculated by PMS-2 and the amount of change in VAS reported by subjects
(3) Correlation between the amount of change in PS calculated by PMS-2 and the amount of change in NRS reported by the subject
(4) Correlation between the rate of change in PS calculated by PMS-2 and the rate of change in VAS reported by subjects
(5) Correlation between the rate of change in PS calculated by PMS-2 and the rate of change in NRS reported by subjects
(6) Correlation between PS calculated by PMS-2 and VAS reported by subjects
(7) Correlation between PS calculated by PMS-2 and NRS reported by subjects

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who are 20 years of age or older at the time consent is obtained
(2) Patients scheduled to undergo surgery under general anesthesia
(3) Gender: any gender
(4) Patients who have given written consent of their own free will

Exclude criteria

(1) Patients with known or pre-existing neurological disorders such as epilepsy
(2) Patients taking narcotic analgesics
(3) Patients with a history of cerebral infarction or hemorrhage
(4) Patients with a history of other organic brain diseases
(5) Patients already diagnosed with chronic pain
(6) Patients with cardiac pacemakers or electronic implants
(7) Patients with severe visual impairment
(8) Women of childbearing potential
(9) Patients with apparent cognitive impairment
(10) Patients scheduled for an MRI scan at the time of EEG electrode placement during the observation period
(11) Patients who are judged by the investigator or subinvestigator to be inappropriate to participate in this clinical trial.

Related Information

• Primary Sponsor: Nakai Kunihiro
• Secondary Sponsor: PaMeLa Inc.
• Source(s) of Monetary Support: Japan Agency for Medical Research and development