NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs062240013

Registered date:17/05/2024

HFVI Study

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedOsteoarthritis
Date of first enrollment25/06/2024
Target sample size50
Countries of recruitment
Study typeInterventional
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 OutcomeAmount 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 - Complications including postoperative nausea and vomiting (PONV) - Vital signs during surgery - HFVI values for both groups

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1.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 criteria1. 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

Contact

Public contact
Name Yuto Matsuoka
Address 2-5-1 Shikatacho, Kitaku, Okayama Okayama Japan 700-8558
Telephone +81-86-235-7330
E-mail me421078@s.okayama-u.ac.jp
Affiliation Okayama University Hospital
Scientific contact
Name Hiroshi Morimatsu
Address 2-5-1 Shikatacho, Kitaku, Okayama Okayama Japan 700-8558
Telephone +81-86-235-7327
E-mail pb9b45wr@okayama-u.ac.jp
Affiliation Okayama University Hospital