Comparison between devices of 'pain' monitors

Comparison of analgesic level index between nociceptive stimulation monitor devices - A prospective observational study - Comparison of analgesic level index between nociceptive stimulation monitor devices - A prospective observational study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049262

Enrollment

100

Registered

2022-10-19

Start date

2022-10-21

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

osteoarthritis of the knee / spinal degenerative disease / cerebral aneurysm / brain tumor / uterine myoma / ovarian tumor / labor epidural analgesia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The following patients undergoing surgery at Nara Medical University Hospital Laparoscopic gynecological surgery (myomectomy, total hysterectomy, ovarian tumor removal, ovarian tumor enucleation) Total knee arthroplasty Spine surgery (spinal fusion, vertebroplasty) Neurosurgery Cesarean section Patients undergoing scheduled surgery while on maintenance dialysis using a forearm shunt Pregnant women who are scheduled to have labor epidural analgesia at Nara Medical University Hospital (1) Patients who have given written consent of their own free will to participate in this study after receiving sufficient explanation and with full understanding (2) Patients who are 18 years of age or older at the time of obtaining consent.

Exclusion criteria

Exclusion criteria: 1) Patients with known arrhythmia 2) Patients with cardiac pacemakers 3) Patients after heart transplantation 4) Patients taking anticholinergic drugs such as atropine that affect the sinus node 5) Patients with missing fingers 6) Patients with Raynaud's symptoms 7) Other patients who are deemed inappropriate by the principal investigator or principal study investigator.

Design outcomes

Primary

Measure	Time frame
Concordance rate between HFVI and NoL values	—

Secondary

Measure	Time frame
1) Correlation between CRP level on the first postoperative day and intraoperative HFVI and NoL values 2) Relationship between pain at the time of exit operation theater and HFVI and NoL values at that time 3) Rate of change in HFVI or NoL values after the start of insufflation in laparoscopic surgery 4) Changes in HFVI or NoL values for tourniquet pain in total knee arthroplasty 5) Rate of change of HFVI and NoL values for motor evoked potential measurements 6) Changes in HFVI and NoL values during cesarean section and labor epidural analgesia 7) Rate of change of HFVI or NoL values during insufflation and low head position 8) Change in NoL values of the shunt side finger in patients undergoing maintenance hemodialysis with a forearm shunt and the rate of concordance with HFVI.	—

Measure

Time frame

1) Correlation between CRP level on the first postoperative day and intraoperative HFVI and NoL values 2) Relationship between pain at the time of exit operation theater and HFVI and NoL values at that time 3) Rate of change in HFVI or NoL values after the start of insufflation in laparoscopic surgery 4) Changes in HFVI or NoL values for tourniquet pain in total knee arthroplasty 5) Rate of change of HFVI and NoL values for motor evoked potential measurements 6) Changes in HFVI and NoL values during cesarean section and labor epidural analgesia 7) Rate of change of HFVI or NoL values during insufflation and low head position 8) Change in NoL values of the shunt side finger in patients undergoing maintenance hemodialysis with a forearm shunt and the rate of concordance with HFVI.

—

Countries

Japan

Contacts

Public ContactNobuhiro Tanaka

Nara Medical University Department of Anesthesiology

nobuhirotanaka@naramed-u.ac.jp0742-46-6001

Outcome results