Analgesia Nociception Index in Orthognathic Surgery

NCT06205355 — Not applicable, Recruiting, 86 participants, Seoul National University Hospital

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT06205355
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, prevention
Enrollment86 (Estimated)
SponsorSeoul National University Hospital (Other)
ConditionsPostoperative Pain
InterventionsAnalgesia/Nociception Index (ANI) monitoring, Standard monitoring (Device)
Datesstart 2024-01-25 (estimated), primary completion 2026-12-25 (estimated), completion 2026-12-30 (estimated), first posted 2024-01-16, last updated 2024-01-16
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Postoperative Pain All trials of Analgesia/Nociception Index (ANI) monitoring All trials of Standard monitoring

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
goal-directed analgesia using ANI monitoringExperimentalDevice: Analgesia/Nociception Index (ANI) monitoring
Standard monitoringActive comparatorDevice: Standard monitoring
  • 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

+Outcome measures

Primary outcomes

  • 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.

Secondary outcomes

  • Patient satisfaction [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.
  • intraoperative opioid consumption [during surgery]: total dose of remifentanil consumption during surgery
  • intraoperative non-opioid consumption [during surgery]: total dose of non-opioid consumption during surgery
  • intraoperative use of vasoactive drugs [during surgery]: total dose 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]
  • 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 [during surgery]
  • estimated blood loss [during surgery]
  • total fluid administration during surgery [during surgery]
  • extubation time [from the end of surgery to endotracheal tube extubation, up to 30 minutes]
  • number of participants with postoperative nausea vomiting [24 hours after the end of surgery]
  • number of participants with postoperative opioid-related side effects (constipation, pruritis, dizziness, dry mouth, somnolence) [24 hours after the end of surgery]
  • Total postoperative opioid consumption [24 hours after the end of surgery]
  • Total postoperative non-opioid consumption [24 hours after the end of surgery]
  • postoperative pain measured by numerical rating scale (NRS) scale (minimum 0, maximum 10, higher scores mean worse outcome) [24 hours after the end of surgery]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Seoul National University Children's HospitalSeoulSouth KoreaRecruiting