NCT07269106招募中4 期
Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery: A Multicenter, Randomized, Parallel-Control, Non-Inferiority Trial
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 3
- 主要终点
- Cumulative pain severity at rest during the first 6 hours after surgery, measured with the Numeric Rating Scale (0-10, higher scores = worse pain)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
The Anrikefon Group
Experimental
Intravenous injection of Anrikefon 1 μg/kg will be administered 15 minutes before the end of surgery
干预措施: Anrikefon (Drug)
The Nalbuphine Group
Active Comparator
Intravenous injection of nalbuphine 0.1 mg/kg will be administered 15 minutes before the end of surgery
干预措施: Nalbuphine (Drug)
结局指标
主要结局
Cumulative pain severity at rest during the first 6 hours after surgery, measured with the Numeric Rating Scale (0-10, higher scores = worse pain)
时间窗: In the PACU and at 1 , 2 , 4 and 6 hours after surgery
Pain intensity at rest is recorded with the Numeric Rating Scale (NRS: 0 = no pain, 10 = worst possible pain). The area under the curve (AUC) for these scores will be calculated with the trapezoidal rule, using assessments performed in the PACU and at 1 , 2 , 4 and 6 hours post-operatively. A higher AUC indicates greater cumulative pain over the 6-hour period.
次要结局
- Pain severity at rest and during eye movement, measured with the Numeric Rating Scale (0-10, higher scores = worse pain)(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(In the PACU and at 1, 2, 4, 6, 12, and 24 hours postoperatively)
- Uncorrected visual acuity (UCVA) [LogMAR](At 24 hours, 1 week, and 1 month postoperatively)
- Best-corrected visual acuity (BCVA) [LogMAR](At 24 hours, 1 week, and 1 month 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(At 6, 12, and 24 hours postoperatively)
- Satisfaction score of analgesia within 24 hours postoperatively(Within 24 hours postoperatively)
- Emergence time(Through surgery completion, an average of 1 hour.)
- Percentage of patients not requiring rescue analgesics(At 6, 12, and 24 hours postoperatively)
- Time to first ambulation(Through surgery completion, an average of 24 hours.)
- PACU stay time(Through surgery completion, an average of 2 hours.)
- Postoperative hospital stay(Through surgery completion, an average of 24 hours)
- Incidence of postoperative complications in the PACU and within 24 hours postoperatively(In the PACU and within 24 hours postoperatively)
- Postoperative 24-hour recovery quality assessed using the 15-item Quality of Recovery questionnaire (QoR-15)(At 24 hours postoperatively)
- Intraocular pressure (IOP) [mmHg](At 24 hours, 1 week, and 1 month postoperatively)
- Orbital pressure [digital palpation grade](At 24 hours, 1 week, and 1 month postoperatively)
研究者
Xiaoliang Gan
Director of the Department of Anesthesiology
Zhongshan Ophthalmic Center, Sun Yat-sen University
研究点 (3)
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