Postoperative Pain
Conditions
Brief summary
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.
Interventions
DEVICEAnalgesia/Nociception Index (ANI) monitoring
intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to ANI monitor.
DEVICEStandard monitoring
intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to the clinician's decision
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients 18 or older undergoing maxillary, mandibular, or bimaxillary surgery under general anesthesia. * adult patients who can provide written informed consent to participate in the study, understand the procedures of this study, and be able to complete patient-reported questionnaires adequately. * adult patients who Have made an informed decision to participate in this study and have given written consent.
Exclusion criteria
* Patients with ASA physical status 4-5 * Emergency surgery * Patients with chronic pain and related pain medications * Patients with hypersensitivity to general anesthesia drugs and pain medications * Patients with arrhythmia * Pregnant women * Others deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative QoR-15K score | 24 hours after the end of surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of participants with postoperative nausea vomiting | 24 hours after the end of surgery | — |
| Patient satisfaction | 24 hours after the end of surgery | 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. |
| intraoperative opioid consumption | during surgery | total dose of remifentanil consumption during surgery |
| intraoperative non-opioid consumption | during surgery | total dose of non-opioid consumption during surgery |
| intraoperative use of vasoactive drugs | during surgery | total dose of vasoactive drugs 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 | — |
| extubation time | from the end of surgery to endotracheal tube extubation, up to 30 minutes | — |
| estimated blood loss | during surgery | — |
| total fluid administration during surgery | during 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 | — |
| 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 | — |
Countries
South Korea
Outcome results
None listed