JPRN-jRCT2052200025CompletedPhase 2
An exploratory Investigator Initiated clinical trial for the development of PMS-1, a device for objectively monitoring the efficacy of analgesics on postoperative pain
akai Kunihiro0 sites30 target enrollmentStarted: June 8, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
The PS measured by the Pain Management System PMS-1 correlated with the amount of change in the NRS and VAS measurements, which are commonly used to measure and evaluate pain in daily practice, and could be used as an indicator to monitor the efficacy of analgesics for postoperative pain. In addition, it was confirmed that patients scheduled to undergo surgery under general anesthesia were the target patients for whom the pain performance evaluation of the device concerned could be appropriately conducted.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
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
- •(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
Investigators
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