Anrikefon versus nalbuphine for pain control after eye surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 18–70 undergoing ophthalmic surgery under general anesthesia will receive an intravenous dose of either Anrikefon or nalbuphine during the perioperative period and will be followed for pain, side effects, and recovery. The phase 4 interventional comparison is designed to determine whether Anrikefon is not inferior to nalbuphine for postoperative analgesia while producing fewer central side effects such as sedation or dizziness. Researchers will record pain scores, adverse events, and recovery metrics including time to discharge after day-surgery procedures, with follow-up assessments to capture safety and recovery outcomes. Results will help determine if Anrikefon can offer effective and safer perioperative pain management for ophthalmic day-surgery patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* History of cardiovascular or cerebrovascular events within the past 6 months, including unstable angina, ischemic myocardial infarction, or heart failure; or current presence of uncontrolled hypertension (\>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 such as brain injury or seizures, as well as severe psychiatric illnesses.
* Known allergy to kappa opioid receptor agonists or to general anesthetic agents used in this study.
* Current peptic ulcer disease, gastrointestinal bleeding, or known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs), such as flurbiprofen axetil or paracetamol.
* Prior use of opioid or non-opioid analgesics, with the last administration occurring within five half-life periods of the drug.
* Continuous use of opioid analgesics for more than 10 days within the 3 months prior to screening.
* Use of drugs with unknown half-life periods that may affect analgesic efficacy within 14 days before randomization.
* History of major surgery within the past 3 months that may interfere with postoperative pain assessment.

Where it's running

• Zhongshan Ophthalmic Center, Sun Yat-Sen University
  Guangzhou, Guangdong, China Recruiting
• The Affiliated Hospital of Yunnan University
  Kunming, Yunnan, China Not yet recruiting
• Eye & ENT Hospital of Fudan University
  Shanghai, China Not yet recruiting

Study contacts

• Study coordinator: Xiaoliang Gan, PhD
• Email: ganxl@mail.sysu.edu.cn
• Phone: 0086-13688893908

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.