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Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery

NCT07269106 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2026-04-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-22
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07269106 on ClinicalTrials.gov