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PMS-1 exploratory Investigator Initiated clinical trial

An exploratory Investigator Initiated clinical trial for the development of PMS-1, a device for objectively monitoring the efficacy of analgesics on postoperative pain

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2052200025
Enrollment
30
Registered
2020-06-08
Start date
2020-09-02
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

atients scheduled to undergo surgery under general anesthesia

Interventions

Electroencephalogram is measured after preoperative examination for this clinical trial to 6 hours after leaving the operating room

Sponsors

Nakai Kunihiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients 20 years or older at the time of consent acquisition (2) Patients scheduled to undergo surgery under general anesthesia (3) Patients with no apparent cognitive impairment (4) Gender: Any (5) Patients who have their own free written consent

Exclusion criteria

Exclusion criteria: (1) Patients with known neurological disorders such as epilepsy, or patients with a history (2) Patients taking narcotic analgesics (3) Patients with a history of cerebral infarction and cerebral hemorrhage (4) Patients with a history of other organic brain diseases (5) Patients who have already been diagnosed with chronic pain (6) Patients with cardiac pacemakers or electronic implants (7) Patients with severe visual impairment (8) Women who may be pregnant (9) Patients who are judged by the investigator or the investigator to be inappropriate to participate in this clinical trial

Design outcomes

Primary

MeasureTime frame
(1) Estimated pain value PS calculated by PMS-1 and its rate of change (2) Estimated pain value PS calculated by PMS-1 and its change amount (3) Correlation between the rate of change in NRS reported by patients and the rate of change in estimated pain value PS calculated by PMS-1 (4) Correlation between the amount of change in NRS reported by the patient and the amount of change in estimated pain value PS calculated by PMS-1 (5) Correlation between the rate of change of VAS (Visual Analogue Scale) reported by the patient and the rate of change of estimated pain value PS calculated by PMS-1 (6) Correlation between the amount of change in VAS declared by the patient and the amount of change in estimated pain value PS calculated by PMS-1 (7) Correlation between the rate of change of SFMPQ-2 reported by the patient and the rate of change of estimated pain value PS calculated by PMS-1 (8) Correlation between the amount of change in SFMPQ-2 reported by the patient and the amount of change in the estimated pain value PS calculated by PMS-1 (9) Correlation between rate of change in blood pressure and rate of change in estimated pain value PS calculated by PMS-1 (10) Correlation between the amount of change in blood pressure and the amount of change in the estimated pain value PS calculated by PMS-1 (11) Correlation between rate of change in pulse rate and rate of change in estimated pain value PS calculated by PMS-1 (12) Correlation between amount of change in pulse rate and amount of change in estimated pain value PS calculated by PMS-1 (13) Correlation between rate of change in pulse wave amplitude and rate of change in estimated pain value PS calculated by PMS-1 (14) Correlation between the amount of change in pulse wave amplitude and the amount of change in estimated pain value PS calculated by PMS-1

Secondary

MeasureTime frame
This clinical trial is an exploratory clinical trial, and we do not separately set the main and secondary evaluation items.

Contacts

Public ContactHideaki Harada

Osaka University Hospital

hideaki.harada@dmi.med.osaka-u.ac.jp+81-6-6210-8289

Outcome results

None listed

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