PMS-1 exploratory Investigator Initiated clinical trial

JRCT ID: jRCT2052200025

Registered date:08/06/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: atients scheduled to undergo surgery under general anesthesia
• Date of first enrollment: 02/09/2020
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Electroencephalogram is measured after preoperative examination for this clinical trial to 6 hours after leaving the operating room

Outcome(s)

Primary Outcome

(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 Outcome: This clinical trial is an exploratory clinical trial, and we do not separately set the main and secondary evaluation items.

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

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