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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Scheduled for ophthalmic surgery under general anesthesia.

• Aged 18 to 70 years.

• With American Society of Anesthesiologists (ASA) physical status I to III.

• Body mass index (BMI) between 18 and 30 kg/m²

• Agree to participate in the trial and provide written informed consent.

Locations
Other Locations
China
Zhongshan Ophthalmic Center, Sun Yat-Sen University
RECRUITING
Guangzhou
The Affiliated Hospital of Yunnan University
NOT_YET_RECRUITING
Kunming
Eye & ENT Hospital of Fudan University
NOT_YET_RECRUITING
Shanghai
Contact Information
Primary
Xiaoliang Gan, PhD
ganxl@mail.sysu.edu.cn
0086-13688893908
Backup
Yanling Zhu, MD
zhuyling8@mail.sysu.edu.cn
0086-18898600243
Time Frame
Start Date: 2026-01-22
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 204
Treatments
Experimental: The Anrikefon Group
Intravenous injection of Anrikefon 1 μg/kg will be administered 15 minutes before the end of surgery
Active_comparator: The Nalbuphine Group
Intravenous injection of nalbuphine 0.1 mg/kg will be administered 15 minutes before the end of surgery
Related Therapeutic Areas
Sponsors
Leads: Zhongshan Ophthalmic Center, Sun Yat-sen University

This content was sourced from clinicaltrials.gov