Analgesia Nociception Index in Orthognathic Surgery

Seoul National University

Status: Enrolling

Conditions: Postoperative Pain

Treatments: Device: Analgesia/Nociception Index (ANI) monitoring; Device: Standard monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06205355

H-2310-152-1481

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

goal-directed analgesia using ANI monitoring

Experimental group

Treatment:

Device: Analgesia/Nociception Index (ANI) monitoring

Standard monitoring

Active Comparator group

Treatment:

Device: Standard monitoring