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Recruiting NCT06205355

Analgesia Nociception Index in Orthognathic Surgery

No phase Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Analgesia/Nociception Index (ANI) monitoring, Standard monitoring.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

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

Primary outcome measures

  • Postoperative QoR-15K score [Time frame: 24 hours after the end of surgery]
Secondary outcome measures (12)
  • Patient satisfaction [Time frame: 24 hours after the end of surgery]
  • intraoperative opioid consumption [Time frame: during surgery]
  • intraoperative non-opioid consumption [Time frame: during surgery]
  • intraoperative use of vasoactive drugs [Time frame: 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. [Time frame: during surgery]
  • 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]
  • estimated blood loss [Time frame: during surgery]
  • total fluid administration during surgery [Time frame: during surgery]
  • extubation time [Time frame: from the end of surgery to endotracheal tube extubation, up to 30 minutes]
  • number of participants with postoperative nausea vomiting [Time frame: 24 hours after the end of surgery]
  • number of participants with postoperative opioid-related side effects (constipation, pruritis, dizziness, dry mouth, somnolence) [Time frame: 24 hours after the end of surgery]
  • Total postoperative opioid consumption [Time frame: 24 hours after the end of surgery]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • Seoul National University Children's Hospital — Seoul

Identifiers

NCT: NCT06205355 · H-2310-152-1481

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗