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Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

117

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Guangdong
      • Guangzhou、Guangdong、中国、510000
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Anruikefon 1 μg/kg per dose Group
Anruikefon 1 μg/kg per dose, once every 8 hours (q8h), for a total of 6 doses.
Anruikefon 1 μg/kg/dose, once every 8 hours (q8h), for a total of 6 doses.
实验性的:Anruikefon 100 μg per dose Group
Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.
Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.
安慰剂比较:Placebo Group
0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Consumption of sufentanil via PCIA within 48 hours after the first study drug administration
大体时间:0-48 hours post first study drug dose
0-48 hours post first study drug dose

次要结果测量

结果测量
大体时间
Proportion of rescue analgesia
大体时间:Within0-24 hours and 0-48 hours after the first study drug administration
Within0-24 hours and 0-48 hours after the first study drug administration
Cumulative consumption dose of rescue analgesia
大体时间:within 0-24 hours and 0-48 hours after the first study drug administration
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)
大体时间:Throughout the inpatient hospital stay after surgery, from the end of surgery until the first flatus occurs
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)
大体时间:Throughout the inpatient hospital stay after surgery, from the end of surgery until the first defecation occurs
Throughout the inpatient hospital stay after surgery, from the end of surgery until the first defecation occurs
Time from the end of surgery to first ambulation (hours)
大体时间:Throughout the inpatient hospital stay after surgery, from the end of surgery until the first ambulation occurs
Throughout the inpatient hospital stay after surgery, from the end of surgery until the first ambulation occurs
Incidence of nausea, vomiting and PONV
大体时间:Within 48 hours after the first study drug administration
Within 48 hours after the first study drug administration
Patient satisfaction score for analgesia
大体时间:Within 48 hours after the first study drug administration
Within 48 hours after the first study drug administration
Proportion of subjects with resting numerical rating scale (NRS) pain score ≥ 3
大体时间:Within 0-24 hours and 0-48 hours after the first study drug administration
Within 0-24 hours and 0-48 hours after the first study drug administration
Resting numerical rating scale (NRS) pain score
大体时间:At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
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
大体时间:At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
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
大体时间:Within 48 hours after the first study drug administration
Within 48 hours after the first study drug administration
Cumulative dose of rescue antiemetic treatment
大体时间:Within 48 hours after the first study drug administration
Within 48 hours after the first study drug administration
Incidence of serious adverse events and study drug-related adverse events
大体时间:Throughout the inpatient hospital stay after surgery, from the end of surgery until hospital discharge
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)
大体时间:On the single night following the first administration of study drug
On the single night following the first administration of study drug
Cumulative consumption of sufentanil delivered via patient-controlled intravenous analgesia (PCIA)
大体时间:Within 24 hours after the first study-drug administration
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)
大体时间:Preoperative baseline (prior to surgical incision), and within the interval from 24 hours to 48 hours after the first administration of study drug
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
大体时间:Within 0-24 hours and 0-48 hours after the first study-drug administration
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)
大体时间:Within 48 hours after the first study-drug administration
Within 48 hours after the first study-drug administration
Cumulative opioid consumption, converted to intravenous morphine milligram equivalents (MME)
大体时间: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
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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Changzhen Shang、Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月30日

初级完成 (估计的)

2027年7月1日

研究完成 (估计的)

2027年7月30日

研究注册日期

首次提交

2026年7月29日

首先提交符合 QC 标准的

2026年9月2日

首次发布 (实际的)

2026年9月3日

研究记录更新

最后更新发布 (实际的)

2026年9月3日

上次提交的符合 QC 标准的更新

2026年9月2日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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