NCT07269106

Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery

Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery: A Multicenter, Randomized, Parallel-Control, Non-Inferiority Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ophthalmic Surgery
• Postoperative Pain Management
• Opioid Analgesia

Interventions

Type	Name	Description
DRUG	Anrikefon	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.
DRUG	Nalbuphine	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.

Timeline

• Start date: 2026-01-22
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-12-08
• Last updated: 2026-04-01

Locations

3 sites across 1 country: China