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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| goal-directed analgesia using ANI monitoring | Experimental |
| |
| Standard monitoring | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analgesia/Nociception Index (ANI) monitoring | Device | intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to ANI monitor. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours after the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours after the end of surgery |
| intraoperative opioid consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Children's Hospital | Recruiting | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000698 | Analgesia |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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| Standard monitoring | Device | intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to the clinician's decision |
|
total dose of remifentanil consumption during surgery
| during surgery |
| intraoperative non-opioid consumption | total dose of non-opioid consumption during surgery | during surgery |
| intraoperative use of vasoactive drugs | total dose of vasoactive drugs during surgery | 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. | 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 | during surgery |
| estimated blood loss | during surgery |
| total fluid administration during surgery | during surgery |
| extubation time | from the end of surgery to endotracheal tube extubation, up to 30 minutes |
| number of participants with postoperative nausea vomiting | 24 hours after the end of surgery |
| number of participants with postoperative opioid-related side effects (constipation, pruritis, dizziness, dry mouth, somnolence) | 24 hours after the end of surgery |
| Total postoperative opioid consumption | 24 hours after the end of surgery |
| Total postoperative non-opioid consumption | 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) | 24 hours after the end of surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |