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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1052230029

Enrollment

Registered

2023-05-28

Start date

2024-03-06

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

Patients scheduled to undergo surgery under general anesthesia general anesthesia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Amount of change in PS calculated by PMS-2 over time	—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

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Contacts

Public ContactKunihiro Nakai

University of Fukui Hospital

knakai@u-fukui.ac.jp+81-776-61-3111

Outcome results