Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery

Официальное название

Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery: A Multicenter, Randomized, Parallel-Control, Non-Inferiority Trial

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Cumulative pain severity at rest during the first 6 hours after surgery, measured with the Numeric Rating Scale (0-10, higher scores = worse pain) [Срок оценки: In the PACU and at 1 , 2 , 4 and 6 hours after surgery]

Вторичные конечные точки (12)

• Pain severity at rest and during eye movement, measured with the Numeric Rating Scale (0-10, higher scores = worse pain) [Срок оценки: In the PACU and at 1, 2, 4, 6, 12 and 24 hours, as well as 1 week and 1 month postoperatively]
• Cumulative pain severity during eye movement (0-6 hours) and at rest/during eye movement (0-12 hours and 0-24 hours), measured with the Numeric Rating Scale [Срок оценки: In the PACU and at 1, 2, 4, 6, 12, and 24 hours postoperatively]
• Cumulative consumption of rescue analgesics (flurbiprofen axetil in the PACU and paracetamol after discharge from the PACU) within 6, 12, and 24 hours postoperatively, as well as the time to first use [Срок оценки: At 6, 12, and 24 hours postoperatively]
• Percentage of patients not requiring rescue analgesics [Срок оценки: At 6, 12, and 24 hours postoperatively]
• Satisfaction score of analgesia within 24 hours postoperatively [Срок оценки: Within 24 hours postoperatively]
• Emergence time [Срок оценки: Through surgery completion, an average of 1 hour.]
• PACU stay time [Срок оценки: Through surgery completion, an average of 2 hours.]
• Time to first ambulation [Срок оценки: Through surgery completion, an average of 24 hours.]
• Postoperative hospital stay [Срок оценки: Through surgery completion, an average of 24 hours]
• Incidence of postoperative complications in the PACU and within 24 hours postoperatively [Срок оценки: In the PACU and within 24 hours postoperatively]
• Postoperative 24-hour recovery quality assessed using the 15-item Quality of Recovery questionnaire (QoR-15) [Срок оценки: At 24 hours postoperatively]
• Intraocular pressure (IOP) [mmHg] [Срок оценки: At 24 hours, 1 week, and 1 month postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Zhongshan Ophthalmic Center, Sun Yat-Sen University — Гуанчжоу
• The Affiliated Hospital of Yunnan University — Куньмин
• Eye & ENT Hospital of Fudan University — Шанхай

Публикации

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• Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802. PMID 23268518
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• Wang K, Chen M, Xu F, Zhang F, Liu L, Liu X, Sun Z, Zhao W, Wang Y, Yang J. Population pharmacokinetic modeling and exposure-response analysis of anrikefon: insights and implications in clinical analgesia. Expert Rev Clin Pharmacol. 2025 Jan-Feb;18(1-2):77-88. doi: 10.1080/17512433.2025.2449983. Epub 2025 Jan 23. PMID 39825476
• Zhang XM, Lun MH, Du W, Ma F, Huang ZQ. The kappa-Opioid Receptor Agonist U50488H Ameliorates Neuropathic Pain Through the Ca2+/CaMKII/CREB Pathway in Rats. J Inflamm Res. 2022 May 23;15:3039-3051. doi: 10.2147/JIR.S327234. eCollection 2022. PMID 35645576

Идентификаторы

NCT: NCT07269106 · IIT2025115

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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