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

Seoul National University Hospital1 site in 1 country86 target enrollmentJanuary 25, 2024

ConditionsPostoperative Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Postoperative Pain
Sponsor: Seoul National University Hospital
Enrollment: 86
Locations: 1
Primary Endpoint: Postoperative QoR-15K score
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 25, 2024

End Date

December 30, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Eun-hee Kim

professor

Seoul National University Hospital

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

Outcomes

Primary Outcomes

Postoperative QoR-15K score

Time Frame: 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

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)
intraoperative opioid consumption(during surgery)
Total postoperative non-opioid consumption(24 hours after the end of surgery)
Patient satisfaction(24 hours after the end of surgery)
intraoperative 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)
number of participants with postoperative nausea vomiting(24 hours after the end of surgery)
Total postoperative opioid consumption(24 hours after the end of surgery)