Analgesia Nociception Index in Orthognathic Surgery

Not Applicable

Recruiting

• Conditions: Postoperative Pain
• Interventions: Device: Analgesia/Nociception Index (ANI) monitoring; Device: Standard monitoring

• Registration Number: NCT06205355
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-13
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Study First Posted: 2024-01-16
• Last Update Posted: 2024-01-16
• Study Start: 2024-01-25
• Primary Completion: 2026-12-25
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
goal-directed analgesia using ANI monitoring	Analgesia/Nociception Index (ANI) monitoring	-
Standard monitoring	Standard monitoring	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Total postoperative opioid consumption	24 hours after the end of surgery
intraoperative opioid consumption	during surgery	total dose of remifentanil consumption during surgery
Total postoperative non-opioid consumption	24 hours after the end of surgery
total fluid administration during surgery	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
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 non-opioid consumption	during surgery	total dose of non-opioid consumption during surgery
extubation time	from the end of surgery to endotracheal tube extubation, up to 30 minutes
number of participants with postoperative opioid-related side effects (constipation, pruritis, dizziness, dry mouth, somnolence)	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
intraoperative use of vasoactive drugs	during surgery	total dose of vasoactive drugs during surgery
number of participants with postoperative nausea vomiting	24 hours after the end of surgery

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of