Actively Recruiting
Phase 4
Age: 18Years - 70Years
All Genders
ID07269106
Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery: A Multicenter, Randomized, Parallel-Control, Non-Inferiority Trial
Led by Zhongshan Ophthalmic Center, Sun Yat-sen University · Updated on 2026-04-01
204
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether Anrikefon works as well as nalbuphine to manage pain after ophthalmic surgery in adults under general anesthesia. This clinical trial focuses on comparing the pain relief, side effects like sedation or dizziness, and recovery speed between Anrikefon and nalbuphine. The goal is to see if Anrikefon can provide effective and safer pain control for patients undergoing eye surgery as day procedures. Participants will receive an intravenous dose of either Anrikefon at 1 microgram per kilogram or nalbuphine at 0.1 milligram per kilogram, given 15 minutes before the end of surgery. The study is randomized and includes two groups: one receiving Anrikefon and the other nalbuphine. Both treatments will be carefully monitored throughout the surgery and recovery periods. During the study, participants' pain levels will be measured at rest and during eye movement using a numeric scale at various times up to one month after surgery. Other assessments include the need for additional pain medications, recovery quality, hospital stay length, and eye health measures such as intraocular pressure and visual acuity. Safety and side effects will be tracked closely, with follow-up visits scheduled up to one month postoperatively. The total study participation covers surgery and subsequent recovery monitoring.
CONDITIONS
Brief Title
Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
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/m²
- Agree to participate and provide written informed consent
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 (>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
- Severe psychiatric illnesses
- Known allergy to kappa opioid receptor agonists or general anesthetic agents used in this study
- Current peptic ulcer disease or gastrointestinal bleeding
- Known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) like flurbiprofen axetil or paracetamol
- Prior use of opioid or non-opioid analgesics within five half-life periods of the drug
- Continuous opioid use for more than 10 days within 3 months prior to 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 interfere with postoperative pain assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day and up to 24 hours postoperatively
Participants undergo ophthalmic surgery under general anesthesia and receive a single intravenous injection of either Anrikefon or Nalbuphine 15 minutes before the end of surgery for postoperative pain management.
1 surgery visit and monitoring in the Post-Anesthesia Care Unit (PACU) for approximately 2 hours
Post-operative Follow-up
Duration - Up to 1 month postoperatively
Participants are monitored for pain severity, analgesic use, recovery quality, visual acuity, intraocular pressure, and orbital pressure at multiple time points up to 1 month after surgery.
Visits at 1, 2, 4, 6, 12, and 24 hours; and at 1 week and 1 month postoperatively
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
Y
Yanling Zhu, MD
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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https://pubmed.ncbi.nlm.nih.gov/32724245Intraoperative administration of intravenous flurbiprofen axetil with nalbuphine reduces postoperative pain after orbital decompression: a single-center, prospective randomized controlled trial.
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