Analgesia Nociception Index in Orthognathic Surgery

NCT06205355 · tracked via the Priya Life Science South Korea tracker

Sponsor

Seoul National University Hospital

Phase

Not applicable

Started

2024-01-25

Last updated

2024-01-16

Condition(s) studied

Postoperative Pain

Investigational drug(s) / intervention(s)

Analgesia/Nociception Index (ANI) monitoringStandard monitoring

Analgesia/Nociception Index (ANI) monitoring: intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to ANI monitor.

Standard monitoring: intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to the clinician's decision

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Seoul National University Children's Hospital	Seoul	South Korea	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06205355 on ClinicalTrials.gov ↗ ← All trials in South Korea