Actively Recruiting

Phase 4
Age: 18Years - 70Years
All Genders
NCT07269106

Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery

Led by Zhongshan Ophthalmic Center, Sun Yat-sen University · Updated on 2026-04-01

204

Participants Needed

3

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled for ophthalmic surgery under general anesthesia
  • Aged 18 to 70 years
  • American Society of Anesthesiologists (ASA) physical status I to III
  • Body mass index (BMI) between 18 and 30 kg/m8
  • Provided written informed consent to participate in the trial
Not Eligible

You will not qualify if you...

  • History of cardiovascular or cerebrovascular events within the past 6 months, including unstable angina, ischemic myocardial infarction, or heart failure
  • Current uncontrolled hypertension (greater than 180/110 mmHg), aneurysm, or severe cardiac arrhythmia
  • Severe respiratory diseases such as pulmonary fibrosis, severe pulmonary abscess, cor pulmonale, or advanced chronic obstructive pulmonary disease (COPD)
  • Significant neurological disorders like brain injury, seizures, or severe psychiatric illnesses
  • Known allergy to kappa opioid receptor agonists or general anesthetic agents used in the study
  • Current peptic ulcer disease, gastrointestinal bleeding, or hypersensitivity to NSAIDs such as flurbiprofen axetil or paracetamol
  • Use of opioid or non-opioid analgesics with last dose within five half-life periods
  • Continuous opioid use for more than 10 days within 3 months before screening
  • Use of drugs with unknown half-life that may affect analgesic efficacy within 14 days before randomization
  • History of major surgery within the past 3 months that may affect postoperative pain assessment

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, China, 510060

Actively Recruiting

2

The Affiliated Hospital of Yunnan University

Kunming, Yunnan, China, 650000

Not Yet Recruiting

3

Eye & ENT Hospital of Fudan University

Shanghai, China, 200031

Not Yet Recruiting

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Research Team

X

Xiaoliang Gan, PhD

CONTACT

Y

Yanling Zhu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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