A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of Anrikefon for Perioperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy (PCNL)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Incidence of composite opioid-related adverse events (ORAEs) within 24 h after surgery
研究概览
简要总结
This study evaluates whether a single dose of anrikefon, given intravenously shortly before the end of kidney stone removal surgery (PCNL), can reduce opioid-related side effects such as nausea, vomiting, itching, oversedation, and breathing problems in the first 24 hours after surgery. All participants receive the same standard pain control regimen (flurbiprofen axetil plus a sufentanil patient-controlled pump). In addition, half receive anrikefon and half receive a placebo (saline), decided by random allocation, with neither patients nor doctors knowing who receives which. A total of 160 adults (18-75 years) undergoing elective PCNL at Beijing Tsinghua Changgung Hospital will take part. Pain scores, opioid use, recovery, satisfaction, kidney function and side effects will be followed for up to 3 days after surgery.
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)
盲法说明
Pharmacists preparing the study drug are unblinded but do not participate in outcome assessment; all other personnel listed above are blinded to allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years, either sex
- •Scheduled elective unilateral percutaneous nephrolithotomy (PCNL) under general anesthesia (stone diameter >2 cm, meeting PCNL indications)
- •ASA classification I-III
- •Body mass index (BMI) 18-35 kg/m2
- •Preoperative estimated glomerular filtration rate (eGFR) >=60 mL/min/1.73 m2
- •Resting pain NRS score <=2 within 24 h before surgery
- •Voluntary participation with written informed consent signed by the patient
- •Ability to cooperate with postoperative pain assessment, follow-up and examinations
排除标准
- •Allergy to anrikefon, sufentanil, flurbiprofen axetil or their excipients
- •Use of opioids, NSAIDs, glucocorticoids or other analgesics within 7 days before surgery
- •Renal dysfunction (eGFR <60 mL/min/1.73 m2) or severe hepatic dysfunction (ALT/AST >3 times upper limit of normal)
- •Severe cardiovascular or respiratory disease (e.g., COPD, respiratory failure)
- •History of gastrointestinal ulcer or bleeding, or coagulation disorders
- •Pregnant or lactating women
- •History of cognitive impairment or drug/alcohol dependence
- •Concurrent participation in other clinical trials
研究组 & 干预措施
Placebo
0.9% saline 5 mL IV 15-30 min before the end of surgery, identical in appearance, added to the same standard multimodal analgesia: flurbiprofen axetil 50 mg IV plus sufentanil PCIA.
干预措施: 0.9% Sodium Chloride Injection as Placebo (Drug)
Anrikefon
Anrikefon 0.1 mg IV (diluted to 5 mL) 15-30 min before the end of surgery, added to standard multimodal analgesia: flurbiprofen axetil 50 mg IV plus sufentanil PCIA.
干预措施: Anrikefon (Drug)
结局指标
主要结局
Incidence of composite opioid-related adverse events (ORAEs) within 24 h after surgery
时间窗: Postoperative hours 0-6, 6-12, and 12-24; composite endpoint assessed over the 24-hour period immediately after surgery
次要结局
- Cumulative sufentanil consumption(Postoperative hours 0-24 and 24-48)
- Pain intensity by numeric rating scale (NRS), 0-10 score(Postoperative hours 0.5, 1, 2, 4, 8, 12, and 24)
- Total and effective patient-controlled analgesia (PCA) bolus counts (number)(Within the first 24 hours after surgery)
- PCA effective bolus ratio (%)(Within the first 24 hours after surgery)
- Rate of patients requiring rescue analgesia (%)(Within the first 24 hours after surgery)
- Number of rescue analgesic doses (count)(Within the first 24 hours after surgery)
- Time to first flatus (hours)(From surgery until the date of first documented flatus, assessed up to 7 days after surgery)
- Time to first ambulation (hours)(From surgery until the date of first ambulation, assessed up to 7 days after surgery)
- Duration of postoperative hospital stay (days)(From surgery until the date of hospital discharge, assessed up to 7 days after surgery)
- Analgesia satisfaction score (0-10)(At postoperative hour 24)
- Serum creatinine and blood urea nitrogen (mg/dL)(Baseline (preoperative) and at postoperative hours 24, 48, and 72)
- Estimated glomerular filtration rate (eGFR, mL/min/1.73 m²)(Baseline (preoperative) and at postoperative hours 24, 48, and 72)
- Incidence of acute kidney injury per KDIGO criteria (%)(Baseline (preoperative) through postoperative hour 72)
- Incidence of adverse events (%)(From study drug administration through postoperative hour 72)
- Area under the curve of NRS scores over 24 hours (AUC₀-₂₄ₕ, score-hours)(Postoperative hours 0-24)
研究者
Zhifeng Gao
Chief Physician, Department of Anesthesiology
Beijing Tsinghua Chang Gung Hospital