HFVI Study

JRCT ID: jRCTs062240013

Registered date:17/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Osteoarthritis
• Date of first enrollment: 17/05/2024
• Target sample size: 50
• Study type: Interventional

Intervention(s)

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 as follows
HFVI 49 or lower: Remifentanil dose is increased by 0.05ug/kg/min.
HFVI 71 or higher: decrease the dose of remifentanil by 0.05ug/kg/min.
2)HFVI uncontrolled group
The HFVI value is measured with HFVI, but the HFVI value is not displayed on the monitor screen. From the start to the end of the surgery, the dose of remifentanil will be adjusted based on clinical monitoring, including vital signs as before.

Outcome(s)

• Primary Outcome: Amount of remifentanil used during surgery

Secondary Outcome

- 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
- Postoperative time to the first administration of analgesia
- Complications including postoperative nausea and vomiting (PONV)
- HFVI values for both groups

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Morimatsu Hiroshi