Analgesia Nociception Index in Orthognathic Surgery
ID: NCT06205355
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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.
intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to ANI monitor.
intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to the clinician's decision
Treatment Arms Description
- 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.
- 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 Outcome Measures
- 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.
View Secondary Outcome Measures (14)
- Patient satisfaction — Time Frame: 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 opioid consumption — Time Frame: during surgery
total dose of remifentanil consumption during surgery
- intraoperative non-opioid consumption — Time Frame: during surgery
total dose of non-opioid consumption during surgery
- intraoperative use of vasoactive drugs — Time Frame: during surgery
total dose of vasoactive drugs 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. — Time Frame: 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 — Time Frame: during surgery
- estimated blood loss — Time Frame: during surgery
- total fluid administration during surgery — Time Frame: during surgery
- extubation time — Time Frame: from the end of surgery to endotracheal tube extubation, up to 30 minutes
- number of participants with postoperative nausea vomiting — Time Frame: 24 hours after the end of surgery
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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View Official Medical/Scientific 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