Clinical trial NCT06205355: Analgesia Nociception Index in Orthognathic Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Postoperative QoR-15K score
timeFrame: 24 hours after the end of surgery
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 24 hours after the end of surgery
measure: intraoperative opioid consumption
timeFrame: during surgery
measure: intraoperative non-opioid consumption
timeFrame: during surgery
measure: intraoperative use of vasoactive drugs
timeFrame: during surgery
measure: The time-weighted average of the segments of the total anesthesia time where the ANI value did not remain above 50 and below 70.
timeFrame: during surgery
measure: 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
timeFrame: during surgery
measure: estimated blood loss
timeFrame: during surgery
measure: total fluid administration during surgery
timeFrame: during surgery
measure: extubation time
timeFrame: from the end of surgery to endotracheal tube extubation, up to 30 minutes
measure: number of participants with postoperative nausea vomiting
timeFrame: 24 hours after the end of surgery
measure: number of participants with postoperative opioid-related side effects (constipation, pruritis, dizziness, dry mouth, somnolence)
timeFrame: 24 hours after the end of surgery
measure: Total postoperative opioid consumption
timeFrame: 24 hours after the end of surgery
measure: Total postoperative non-opioid consumption
timeFrame: 24 hours after the end of surgery
measure: postoperative pain measured by numerical rating scale (NRS) scale (minimum 0, maximum 10, higher scores mean worse outcome)
timeFrame: 24 hours after the end of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
References: