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HFVI Study

High-frequency variability index-guided remifentanil versus standard care in lower extremity arthroplasty during general anesthesia: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062240013
Enrollment
50
Registered
2024-05-17
Start date
2024-06-25
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

Interventions

1)HFVI control group The HFVI is attached, and the HFVI value is measured. The remifentanil dosage is adjusted based on the HFVI value every 5 minutes from the start of surgery to the end of surgery a

Sponsors

Morimatsu Hiroshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients scheduled to undergo unilateral knee or hip replacement under general anesthesia 2.Patients who are 18 years of age or older at the time of consent (regardless of gender) 3.Patients scheduled to enter the PACU after surgery 4.Patients who have received sufficient explanation and informed written consent of their own free will to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of hypersensitivity to medications to be used during anesthesia 2. Patients with a preoperative ASA-PS (American Society of Anesthesiologists Physical Status) of 3 or higher 3. Patients who have undergone surgery under general anesthesia at least 1 week before the scheduled surgery 4. Patients who have been using narcotic analgesics and antiarrhythmic drugs regularly before the surgery 5. Patients with a history of atrial fibrillation 6. Patients with a pacemaker 7. Patients who are undergoing surgery other than TKAt or THA at the same time. 8. Patients who do not understand Japanese and cannot perform NRS evaluation. 9. Other patients judged inappropriate as research subjects by the principal investigator and subinvestigators.

Design outcomes

Primary

MeasureTime frame
Amount of remifentanil used during surgery

Secondary

MeasureTime frame
- NRS from the time of admission to the PACU to the day after surgery - Use of supplemental analgesia from the time of admission to the PACU to the day after surgery - Complications including postoperative nausea and vomiting (PONV) - Vital signs during surgery - HFVI values for both groups

Contacts

Public ContactYuto Matsuoka

Okayama University Hospital

me421078@s.okayama-u.ac.jp+81-86-235-7330

Outcome results

None listed

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