NCT07801183尚未招募4 期
Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy:A Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2026年8月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Consumption of sufentanil via PCIA within 48 hours after the first study drug administration
研究概览
简要总结
A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.
详细描述
A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years;
- •American Society of Anesthesiologists (ASA) physical status classification I-III;
- •Body mass index (BMI): 18 kg/m² ≤ BMI ≤ 30 kg/m²;
- •Patients scheduled to undergo laparoscopic hepatectomy under general anesthesia with estimated operation duration ≤ 5 hours;
- •Agree to participate in this trial and voluntarily sign the informed consent form.
排除标准
- •Patients with a history of severe cardiopulmonary disease, neuropsychiatric disorders, digestive system diseases, chronic dizziness or vestibular dysfunction;
- •Patients undergoing emergency surgery or trauma patients;
- •Intraoperative conversion to open laparotomy;
- •History of abdominal surgery within the past 3 months;
- •Patients undergoing liver transplantation or with metastasis to other organs;
- •Patients requiring synchronous resection of organs other than the gallbladder, extrahepatic bile ducts and intestines due to intraoperative clinical needs;
- •Severe renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m²);
- •Laboratory findings or clinical evaluation indicating hypothyroidism or hypokalemia graded ≥ Grade 3 per CTCAE v6.0;
- •Subjects who experienced nausea, retching or vomiting within 24 hours before anesthesia induction (excluding those caused by bowel preparation);
- •Patients expected to require postoperative mechanical ventilation via endotracheal intubation or naso/orogastric tube placement for more than 24 hours;
- •Known allergy or contraindication to opioids and other anesthetics, antiemetics that may be administered during the trial.
- •Use of drugs with analgesic, antiemetic or anti-inflammatory effects with unknown half-life within 14 days prior to randomization; or the interval between the last administration and randomization is shorter than 5 half-lives or the duration of drug effect (whichever is longer). Such drugs include, but are not limited to, opioid analgesics, non-opioid analgesics, antiemetics (or drugs with antiemetic properties), sedative-hypnotics, sedative anesthetics, glucocorticoids and other drugs with analgesic or antiemetic effects.
- •Subjects with any other factors deemed by the investigator(s) to render them unsuitable for participation in this clinical study.
研究组 & 干预措施
Anruikefon 1 μg/kg per dose Group
Experimental
Anruikefon 1 μg/kg per dose, once every 8 hours (q8h), for a total of 6 doses.
干预措施: Anruikefon 1 μg/kg per dose Group (Drug)
Anruikefon 100 μg per dose Group
Experimental
Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.
干预措施: Anruikefon 100 μg per dose Group (Drug)
Placebo Group
Placebo Comparator
0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
干预措施: Control group (Drug)
结局指标
主要结局
Consumption of sufentanil via PCIA within 48 hours after the first study drug administration
时间窗: 0-48 hours post first study drug dose
次要结局
- Cumulative consumption dose of rescue analgesia(within 0-24 hours and 0-48 hours after the first study drug administration)
- Time from end of surgery to first passage of flatus (hours)(Throughout the inpatient hospital stay after surgery, from the end of surgery until the first flatus occurs)
- Time from end of surgery to first defecation (hours)(Throughout the inpatient hospital stay after surgery, from the end of surgery until the first defecation occurs)
- Proportion of rescue analgesia(Within0-24 hours and 0-48 hours after the first study drug administration)
- Time from the end of surgery to first ambulation (hours)(Throughout the inpatient hospital stay after surgery, from the end of surgery until the first ambulation occurs)
- Incidence of nausea, vomiting and PONV(Within 48 hours after the first study drug administration)
- Patient satisfaction score for analgesia(Within 48 hours after the first study drug administration)
- Proportion of subjects with resting numerical rating scale (NRS) pain score ≥ 3(Within 0-24 hours and 0-48 hours after the first study drug administration)
- Resting numerical rating scale (NRS) pain score(At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration)
- Movement-evoked numerical rating scale (NRS) pain score(At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration)
- Incidence of rescue antiemetic treatment(Within 48 hours after the first study drug administration)
- Cumulative dose of rescue antiemetic treatment(Within 48 hours after the first study drug administration)
- Incidence of serious adverse events and study drug-related adverse events(Throughout the inpatient hospital stay after surgery, from the end of surgery until hospital discharge)
- Sleep quality score assessed using the Richards-Campbell Sleep Questionnaire (RCSQ; score range 0-100, higher scores indicate better sleep quality)(On the single night following the first administration of study drug)
- Cumulative consumption of sufentanil delivered via patient-controlled intravenous analgesia (PCIA)(Within 24 hours after the first study-drug administration)
- Serum biomarker concentrations: alanine transaminase (ALT), aspartate transaminase (AST), albumin (ALB), total bilirubin (TBIL), direct bilirubin (DBIL), indirect bilirubin (IBIL), international normalized ratio (INR)(Preoperative baseline (prior to surgical incision), and within the interval from 24 hours to 48 hours after the first administration of study drug)
- Proportion of subjects with movement-evoked Numerical Rating Scale (NRS) pain score ≥ 3(Within 0-24 hours and 0-48 hours after the first study-drug administration)
- Overall patient recovery quality score evaluated via the QoR-15 questionnaire (score range 0-150; higher scores indicate better recovery quality)(Within 48 hours after the first study-drug administration)
- Cumulative opioid consumption, converted to intravenous morphine milligram equivalents (MME)(Within the interval from 0 hours to 24 hours after the first administration of study drug, and within the interval from 0 hours to 48 hours after the first administration of study drug)
研究者
研究点 (1)
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