NCT07269106 Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery
| NCT ID | NCT07269106 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Zhongshan Ophthalmic Center, Sun Yat-sen University |
| Condition | Ophthalmic Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2026-01-22 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 204 participants in total. It began in 2026-01-22 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07269106 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Ophthalmic Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07269106 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07269106 currently recruiting?
Yes, NCT07269106 is actively recruiting participants. Contact the research team at ganxl@mail.sysu.edu.cn for enrollment information.
Where is the NCT07269106 trial being conducted?
This trial is being conducted at Guangzhou, China, Kunming, China, Shanghai, China.
Who is sponsoring the NCT07269106 clinical trial?
NCT07269106 is sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. The trial plans to enroll 204 participants.