None listed
Conditions
Interventions
Drug : All participants will receive intravenous acetaminophen 1 g approximately 30 minutes before entering the operating room for postoperative analgesia. General anesthesia will be induced and maint
Sponsors
Chonnam National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female patients aged 20 to 60 years. Scheduled to undergo elective gynecologic laparoscopic surgery under general anesthesia. American Society of Anesthesiologists (ASA) physical status I or II. Body mass index (BMI) <30 kg/m². Able to understand the study procedures and voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: Patients undergoing emergency surgery; patients with a body mass index (BMI) =30 kg/m²; patients with American Society of Anesthesiologists (ASA) Physical Status classification III or higher; pregnant patients; patients with an anticipated difficult airway or a high likelihood of delayed tracheal intubation; patients with arrhythmia, atrial fibrillation, an implanted pacemaker, or clinically significant conduction abnormalities; patients with severe cardiovascular disease, unstable angina, or a history of recent myocardial infarction; patients with uncontrolled hypertension (systolic blood pressure =200 mmHg or diastolic blood pressure =110 mmHg at operating room entry); patients taking ß-blockers; patients with diabetes and an HbA1c exceeding 7.0%; patients with diabetes being treated with insulin; patients with a medical record history of diagnosed diabetic autonomic neuropathy or peripheral neuropathy; patients with an eGFR =60 mL/min/1.73 m², AST =120 IU/L, or ALT =120 IU/L; patients with significant neurological or psychiatric disease; patients with chronic opioid use; patients on long-term medications that may affect the autonomic or central nervous system, such as sedatives, antidepressants, antipsychotics, or anticonvulsants; patients with a history of contraindication or hypersensitivity to propofol, remifentanil, dexmedetomidine, acetaminophen, or the rescue medications used in the study; and patients otherwise deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the mean Analgesia Nociception Index (ANIm) measured during the clean analysis window at tracheal intubation (?ANIm) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the mean Analgesia Nociception Index (?ANIm), Entropy (RE/SE), heart rate, and noninvasive blood pressure during clean analysis windows at tetanic stimulation, skin incision or first trocar insertion, and first achievement of a pneumoperitoneum pressure of 12 mmHg;Target effect-site concentrations (Ce) of propofol and remifentanil at each predefined perioperative event;Frequency of rescue remifentanil use in the dexmedetomidine-based opioid-free anesthesia group;Incidence of intubation-related hypertension or tachycardia;Rate of obtaining clean event-analysis windows, event contamination rate, and causes of event contamination;Post-anesthesia care unit numerical rating scale pain score, postoperative nausea and vomiting, and rescue analgesic use | — |
Countries
Korea, Republic of
Contacts
Public ContactJoungmin Kim
Chonnam National University Hospital
Outcome results
None listed