Analgesia Nociception Index in Orthognathic Surgery

NCT06205355 | Recruiting

• 1 other identifier: H-2310-152-1481
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative QoR-15K score

  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.

  24 hours after the end of surgery

Secondary Outcomes (14)

• Patient satisfaction

  24 hours after the end of surgery

• intraoperative opioid consumption

  during surgery

• intraoperative non-opioid consumption

  during surgery

• intraoperative use 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

Study Arms (2)

goal-directed analgesia using ANI monitoring

EXPERIMENTAL

Device: Analgesia/Nociception Index (ANI) monitoring

Standard monitoring

ACTIVE COMPARATOR

Device: Standard monitoring

Interventions

Analgesia/Nociception Index (ANI) monitoring DEVICE

intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to ANI monitor.

goal-directed analgesia using ANI monitoring

Standard monitoring DEVICE

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

Standard monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Children's Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 16, 2024
• Study Start: January 25, 2024
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

KR (1)