Analgesia Nociception Index in Orthognathic Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: Analgesia/Nociception Index (ANI) monitoring; Device: Standard monitoring

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Children's Hospital
    • Contact: Eun-Hee Kim, M.D., Ph.D.; Phone Number: +82-2-2072-3664; Email: beloveun@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard monitoring	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
Experimental: goal-directed analgesia using ANI monitoring	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative QoR-15K score	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.	24 hours after the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
estimated blood loss		during surgery
Patient satisfaction	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.	24 hours after the end of surgery
intraoperative opioid consumption	total dose of remifentanil consumption during surgery	during surgery
intraoperative non-opioid consumption	total dose of non-opioid consumption during surgery	during surgery
intraoperative use of vasoactive drugs	total dose of vasoactive drugs 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
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 25, 2024
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Estimated): January 15, 2024

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: H-2310-152-1481

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No