The goal of this clinical trial is to learn if Anrikefon works as well as nalbuphine to control postoperative pain in adults undergoing ophthalmic surgery under general anesthesia. It will also learn about the safety and recovery outcomes of using Anrikefon. The main questions it aims to answer are: * Does Anrikefon provide pain relief that is not inferior to nalbuphine after ophthalmic surgery? * Does Anrikefon cause fewer central side effects, such as sedation or dizziness, compared with nalbuphine? * Does Anrikefon help patients recover and get discharged faster after day-surgery procedures? Researchers will compare Anrikefon to nalbuphine to see if Anrikefon can offer effective and safer perioperative analgesia for ophthalmic day-surgery patients. Participants will: * Receive either an intravenous dose of Anrikefon or nalbuphine during surgery. * Be monitored for pain scores, side effects, and recovery parameters after surgery. * Complete follow-up assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
Anrikefon is a novel peripherally KOR agonist independently developed in China. In this study, anrikefon will be administered intravenously at a dose of 1 μg/kg, 15 minutes before the end of surgery.
Nalbuphine is a traditional central KOR agonist with mixed μ-opioid receptor antagonist activity. In this study, nalbuphine will be administered intravenously at a dose of 0.1 mg/kg, 15 minutes before the end of surgery.
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGThe Affiliated Hospital of Yunnan University
Kunming, Yunnan, China
NOT_YET_RECRUITINGEye & ENT Hospital of Fudan University
Shanghai, China
NOT_YET_RECRUITINGCumulative pain severity at rest during the first 6 hours after surgery, measured with the Numeric Rating Scale (0-10, higher scores = worse pain)
Pain intensity at rest is recorded with the Numeric Rating Scale (NRS: 0 = no pain, 10 = worst possible pain). The area under the curve (AUC) for these scores will be calculated with the trapezoidal rule, using assessments performed in the PACU and at 1 , 2 , 4 and 6 hours post-operatively. A higher AUC indicates greater cumulative pain over the 6-hour period.
Time frame: In the PACU and at 1 , 2 , 4 and 6 hours after surgery
Pain severity at rest and during eye movement, measured with the Numeric Rating Scale (0-10, higher scores = worse pain)
Participants rate their pain intensity at rest and again during voluntary eye movement using the Numeric Rating Scale (NRS: 0 = no pain, 10 = worst possible pain). Assessments are performed in the PACU and at 1, 2, 4, 6, 12, 24 hours, 1 week, and 1 month post-operatively. Higher scores indicate greater pain.
Time frame: In the PACU and at 1, 2, 4, 6, 12 and 24 hours, as well as 1 week and 1 month postoperatively
Cumulative pain severity during eye movement (0-6 hours) and at rest/during eye movement (0-12 hours and 0-24 hours), measured with the Numeric Rating Scale
The area under the curve (AUC) is computed with the trapezoidal rule, multiplying the average Numeric Rating Scale within each interval by its duration and summing the products; a higher AUC indicates greater cumulative pain.
Time frame: In the PACU and at 1, 2, 4, 6, 12, and 24 hours postoperatively
Cumulative consumption of rescue analgesics (flurbiprofen axetil in the PACU and paracetamol after discharge from the PACU) within 6, 12, and 24 hours postoperatively, as well as the time to first use
In-hospital, participants with resting NRS ≥4 will receive intravenous flurbiprofen axetil 1 mg/kg. Additional doses can be given if ≥3 hours have passed since the previous flurbiprofen dose and ≥1 hour since the last study drug. Breakthrough pain (NRS ≥7) may be treated immediately. Out-of-hospital, participants with resting NRS ≥4 will receive paracetamol 500 mg per dose, up to 2 g per day.
Time frame: At 6, 12, and 24 hours postoperatively
Percentage of patients not requiring rescue analgesics
During the 6-, 12-, and 24-hour postoperative periods, each patient's use of rescue analgesics (flurbiprofen axetil or paracetamol) is recorded. Patients not receiving rescue analgesics are classified as 'not used,' and the percentage is calculated for each group to evaluate postoperative analgesia adequacy.
Time frame: At 6, 12, and 24 hours postoperatively
Satisfaction score of analgesia within 24 hours postoperatively
A trained study assistant assessed satisfaction score of analgesia at rest using a 0 to 10 NRS scale, where 0 indicates 'completely dissatisfied' and 10 indicates 'completely satisfied.'
Time frame: Within 24 hours postoperatively
Emergence time
Emergence time is defined as the interval from stopping anesthetics to eye opening or following simple commands.
Time frame: Through surgery completion, an average of 1 hour.
PACU stay time
PACU stay time is defined as the duration from arrival in PACU to the time of a modified Aldrete score of 9 or 10.
Time frame: Through surgery completion, an average of 2 hours.
Time to first ambulation
Time to first ambulation is defined as the interval from the completion of surgery to the patient's first episode of spontaneous mobilization (i.e., getting out of bed and initiating independent movement).
Time frame: Through surgery completion, an average of 24 hours.
Postoperative hospital stay
Postoperative hospital stay (or in-hospital stay for day-surgery patients) is defined as the interval from the completion of surgery to formal discharge from the hospital.
Time frame: Through surgery completion, an average of 24 hours
Incidence of postoperative complications in the PACU and within 24 hours postoperatively
All assessments of adverse events and medication records will be conducted under double-blind conditions, with evaluators blinded to participant group assignment. The incidence of adverse events will be calculated based on the total number of enrolled participants in each group.
Time frame: In the PACU and within 24 hours postoperatively
Postoperative 24-hour recovery quality assessed using the 15-item Quality of Recovery questionnaire (QoR-15)
Postoperative recovery was assessed using the QoR-15 questionnaire.
Time frame: At 24 hours postoperatively
Intraocular pressure (IOP) [mmHg]
Measured with non-contact tonometer; higher values indicate elevated IOP.
Time frame: At 24 hours, 1 week, and 1 month postoperatively
Orbital pressure [digital palpation grade]
Graded by single examiner via digital palpation.
Time frame: At 24 hours, 1 week, and 1 month postoperatively
Uncorrected visual acuity (UCVA) [LogMAR]
Assessed with standard LogMAR chart; lower LogMAR indicates better acuity.
Time frame: At 24 hours, 1 week, and 1 month postoperatively
Best-corrected visual acuity (BCVA) [LogMAR]
Assessed with standard LogMAR chart after refraction; lower LogMAR indicates better acuity.
Time frame: At 24 hours, 1 week, and 1 month postoperatively
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