Comparison of Goal-directed Analgesia Using ANI (Analgesia/Nociception Index) and Standard Analgesia During General Anesthesia in Patients Undergoing Orthognathic Surgery on Postoperative Quality of Recovery: a Prospective Randomized Controlled Trial
| Registry | NCT06205355 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 86 (Estimated) |
| Sponsor | Seoul National University Hospital (Other) |
| Conditions | Postoperative Pain |
| Interventions | Analgesia/Nociception Index (ANI) monitoring, Standard monitoring (Device) |
| Dates | start 2024-01-25 (estimated), primary completion 2026-12-25 (estimated), completion 2026-12-30 (estimated), first posted 2024-01-16, last updated 2024-01-16 |
| Locations | 1 site in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Postoperative Pain All trials of Analgesia/Nociception Index (ANI) monitoring All trials of Standard monitoring
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| goal-directed analgesia using ANI monitoring | Experimental | Device: Analgesia/Nociception Index (ANI) monitoring | |
| Standard monitoring | Active comparator | Device: Standard monitoring |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Seoul National University Children's Hospital | Seoul | South Korea | Recruiting |