Using ANI to improve pain management after jaw surgery
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
This study tests if using a special pain monitoring tool can help people recover better and manage pain after jaw surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06205355 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of goal-directed analgesia using the Analgesia/Nociception Index (ANI) to enhance postoperative recovery in patients undergoing maxillofacial surgery. By monitoring pain levels through ANI, the study aims to tailor analgesic interventions to individual patient needs. The approach focuses on improving pain management and overall recovery outcomes following surgical procedures involving the maxilla and mandible.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 or older who are scheduled for maxillary, mandibular, or bimaxillary surgery under general anesthesia.
Not a fit: Patients with severe comorbidities, emergency surgery needs, or chronic pain conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better pain control and faster recovery for patients undergoing jaw surgery.
How similar studies have performed: While the use of ANI in pain management is gaining interest, this specific application in maxillofacial surgery is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Seoul National University Children's Hospital — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.