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NCT Number: NCT06205355

Analgesia Nociception Index in Orthognathic Surgery

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Children's Hospital

Seoul, 03080, South Korea

Location status: Recruiting

Location contact

Eun-Hee Kim, M.D., Ph.D.

CONTACT

[email protected]

+82-2-2072-3664

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Postoperative QoR-15K score

    Time frame: 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.

Secondary outcomes

  1. Patient satisfaction

    Time frame: 24 hours after the end of surgery

    Postoperative satisfaction as assessed by study participants blinded to group assignment, recorded on an NRS scale from a low of 0 to a high of 10.

  2. intraoperative opioid consumption

    Time frame: during surgery

    total dose of remifentanil consumption during surgery

  3. intraoperative non-opioid consumption

    Time frame: during surgery

    total dose of non-opioid consumption during surgery

  4. intraoperative use of vasoactive drugs

    Time frame: during surgery

    total dose of vasoactive drugs during surgery

  5. The time-weighted average of the segments of the total anesthesia time where the ANI value did not remain above 50 and below 70.

    Time frame: during surgery

  6. Percentage of time with a deviation of more than ±20% from the mean blood pressure measured on the ward as a percentage of total anesthesia time

    Time frame: during surgery

  7. estimated blood loss

    Time frame: during surgery

  8. total fluid administration during surgery

    Time frame: during surgery

  9. extubation time

    Time frame: from the end of surgery to endotracheal tube extubation, up to 30 minutes

  10. number of participants with postoperative nausea vomiting

    Time frame: 24 hours after the end of surgery

  11. number of participants with postoperative opioid-related side effects (constipation, pruritis, dizziness, dry mouth, somnolence)

    Time frame: 24 hours after the end of surgery

  12. Total postoperative opioid consumption

    Time frame: 24 hours after the end of surgery

  13. Total postoperative non-opioid consumption

    Time frame: 24 hours after the end of surgery

  14. postoperative pain measured by numerical rating scale (NRS) scale (minimum 0, maximum 10, higher scores mean worse outcome)

    Time frame: 24 hours after the end of surgery

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2024
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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