An interventional study of Analgesia/Nociception Index (ANI) monitoring and Standard monitoring in Postoperative Pain, sponsored by Seoul National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-16.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention
This study aims to determine whether goal-directed analgesia using ANI(Analgesia/Nociception Index) can improve the quality of postoperative recovery in patients undergoing maxillofacial surgery.
5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's planned enrollment of 86 is above the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Analgesia/Nociception Index (ANI) monitoring
Device: Standard monitoring
intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to ANI monitor.
intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to the clinician's decision
Postoperative QoR-15K score
Korean-translated QoR-15K (15-item Quality of Recovery (QoR-15) scale, minimum 0, maximum 150, higher scores mean a better outcome ) scores assessed by participants blinded to arm assignment 24 hours after surgery.
Time frame: 24 hours after the end of surgery
Patient satisfaction
Postoperative satisfaction as assessed by study participants blinded to group assignment, recorded on an NRS scale from a low of 0 to a high of 10.
Time frame: 24 hours after the end of surgery
intraoperative opioid consumption
total dose of remifentanil consumption during surgery
Time frame: during surgery
intraoperative non-opioid consumption
total dose of non-opioid consumption during surgery
Time frame: during surgery
intraoperative use of vasoactive drugs
total dose of vasoactive drugs during surgery
Time frame: during surgery
The time-weighted average of the segments of the total anesthesia time where the ANI value did not remain above 50 and below 70.
Time frame: during surgery
Percentage of time with a deviation of more than ±20% from the mean blood pressure measured on the ward as a percentage of total anesthesia time
Time frame: during surgery
estimated blood loss
Time frame: during surgery
total fluid administration during surgery
Time frame: during surgery
extubation time
Time frame: from the end of surgery to endotracheal tube extubation, up to 30 minutes
number of participants with postoperative nausea vomiting
Time frame: 24 hours after the end of surgery
number of participants with postoperative opioid-related side effects (constipation, pruritis, dizziness, dry mouth, somnolence)
Time frame: 24 hours after the end of surgery
Total postoperative opioid consumption
Time frame: 24 hours after the end of surgery
Total postoperative non-opioid consumption
Time frame: 24 hours after the end of surgery
postoperative pain measured by numerical rating scale (NRS) scale (minimum 0, maximum 10, higher scores mean worse outcome)
Time frame: 24 hours after the end of surgery
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Seoul National University Hospital