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Comparison of Goal-Directed Analgesia Using ANI Monitoring and Standard Analgesia During General Anesthesia in Orthognathic Surgery Evaluating Postoperative Quality of Recovery
Led by Seoul National University Hospital · Updated on 2024-01-16
86
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying whether using the Analgesia/Nociception Index (ANI) to guide pain relief during surgery can improve recovery quality after maxillofacial (jaw) surgery. This trial compares goal-directed analgesia guided by ANI monitoring to standard pain management during general anesthesia. The study is a prospective, randomized controlled trial led by Seoul National University Hospital. Participants will undergo maxillary, mandibular, or bimaxillary surgery under general anesthesia. In the experimental group, remifentanil infusion for pain relief is adjusted based on ANI monitoring, a device measuring pain response. In the control group, remifentanil dosing is managed according to the clinician's judgment without ANI guidance. Both groups receive anesthesia and pain management during surgery, with the study assessing differences in recovery. During the study, researchers will assess participants' postoperative recovery quality using the QoR-15K score 24 hours after surgery. They will also measure patient satisfaction, pain levels, opioid and non-opioid drug use during and after surgery, anesthesia details, blood pressure stability, blood loss, fluid administration, extubation time, and side effects like nausea and opioid-related symptoms. The total study duration includes surgery and follow-up assessments within the first 24 hours post-surgery.
CONDITIONS
Brief Title
Analgesia Nociception Index in Orthognathic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years or older undergoing maxillary, mandibular, or bimaxillary surgery under general anesthesia
- Able to provide written informed consent and understand study procedures
- Willing and able to complete patient-reported questionnaires adequately
You will not qualify if you...
- Patients with ASA physical status 4 or 5
- Emergency surgery
- Patients with chronic pain or using related pain medications
- Patients with hypersensitivity to general anesthesia drugs or pain medications
- Patients with arrhythmia
- Pregnant women
- Others deemed unsuitable by the investigator based on medical judgment or study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus up to 30 minutes post-extubation
Participants undergo orthognathic surgery under general anesthesia with analgesia managed either by Analgesia/Nociception Index monitoring or standard monitoring.
1 surgical visit (in-person)
Duration - 24 hours after the end of surgery
Participants are monitored and evaluated for postoperative recovery, pain, opioid consumption, and side effects within 24 hours after surgery.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Seoul National University Children's Hospital
Seoul, South Korea, 03080
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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