Analgesia Nociception Index in Orthognathic Surgery

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205355
• Other study ID #: H-2310-152-1481
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: January 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 30, 2026
• Est. primary completion date: December 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• Standard monitoring
intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to the clinician's decision

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	intraoperative opioid consumption	total dose of remifentanil consumption during surgery	during surgery
Secondary	intraoperative non-opioid consumption	total dose of non-opioid consumption during surgery	during surgery
Secondary	intraoperative use of vasoactive drugs	total dose of vasoactive drugs during surgery	during surgery
Secondary	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
Secondary	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
Secondary	estimated blood loss		during surgery
Secondary	total fluid administration during surgery		during surgery
Secondary	extubation time		from the end of surgery to endotracheal tube extubation, up to 30 minutes
Secondary	number of participants with postoperative nausea vomiting		24 hours after the end of surgery
Secondary	number of participants with postoperative opioid-related side effects (constipation, pruritis, dizziness, dry mouth, somnolence)		24 hours after the end of surgery
Secondary	Total postoperative opioid consumption		24 hours after the end of surgery
Secondary	Total postoperative non-opioid consumption		24 hours after the end of surgery
Secondary	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