NCT07353983尚未招募不适用
Pharmacokinetic Evaluation of Anrikefon Injection in the Geriatric Population With the Management of Acute Pain Following Abdominal Laparoscopy
Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 30 人开始时间: 2026年1月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
This study used a single-center, single-arm, pharmacokinetic ( PK ) study design. Thirty subjects who met the inclusion criteria were stratified according to age, including 15 in each age group of 65-74 years old and ≥ 75 years old. The patients were treated with a unified anesthesia method during abdominal endoscopic surgery. Anrecofin injection 1.0 μg / kg was injected for the first time within 15 min, and then once again at 8 h and 16 h. And received 6 pain assessments, 1 satisfaction score and 1 telephone follow-up. In this study, 10 blood samples were collected and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years, gender unrestricted;
- •American Society of Anesthesiologists (ASA) classification I-III;
- •18 kg/m2 ≤ BMI < 30 kg/m2;
- •Undergoing elective general anesthesia for laparoscopic surgery and expected to experience mild to moderate postoperative pain;
- •Agree to participate in this trial and voluntarily sign the informed consent form.
排除标准
- •There is a history or evidence of any of the following diseases before screening:1) History of cardiovascular diseases: Uncontrolled hypertension (systolic blood pressure ≥160 MMHG and/or diastolic blood pressure ≥90mmHg), as well as a history of cardiovascular diseases evaluated by the researcher as unsuitable for participation in the study, such as severe arrhythmia, heart failure, acute myocardial ischemia, unstable angina pectoris, myocardial infarction, II-III degree atrioventricular block, etc.2) Respiratory system history: Severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, and other respiratory system histories assessed by the researcher as unsuitable for participation in the study;3) History of neurological and mental system diseases: Craniocerebral injury, intracranial hypertension, schizophrenia, mania, cognitive dysfunction, etc., evaluated by the researcher as unsuitable for participation in the study;4) History of digestive system diseases: Suffering from intestinal obstruction or other digestive system diseases that the researcher deems may cause nausea and vomiting;5) Accompanied by a clear history of chronic dizziness, or clearly diagnosed vestibular dysfunction other than motion sickness (including but not limited to: peripheral vestibular syndrome, central vestibular syndrome, etc.);6) Tumor patients who have received chemotherapy and/or radiotherapy within 4 weeks prior to being informed.
- •It is expected that tracheal intubation will continue after the operation or a nasal or oral gastric tube will need to be inserted.
- •Known to be allergic or contraindicated to opioid drugs and other anesthetics and antiemetic drugs that may be used during the trial;
- •Within 3 months prior to screening, there is a history of drug abuse, or continuous use of opioid analgesics for more than 10 days for any reason;
- •Abnormal liver and kidney functions:1) Prothrombin time (PT) is prolonged by more than 3 seconds beyond the upper limit of the normal value;2) Alanine aminotransferase and/or aspartate aminotransferase > 2×ULN;3) Total bilirubin > 1.5×ULN;4) Glomerular filtration rate (eGFR) < 60 mL/min.
- •Have participated in any clinical researchers within the three months prior to the screening;
- •Pregnant and lactating women who have plans to become pregnant during the study period or within 3 months after the study ends;
- •Subjects who the researchers consider to have any other factors that make them unsuitable for participating in this clinical study.
研究者
相似试验
尚未招募
2 期
Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Totally Laparoscopic Radical Distal GastrectomyNCT07330063Tianjin Medical University Cancer Institute and Hospital114
已完成
1 期
A Study Comparing LTG-001 SDD Formulation To LTG-001 Crystalline Immediate Release Tablets In Healthy ParticipantsNCT07341152Latigo Biotherapeutics14
招募中
1 期
A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal SprayNCT07259538VivaVision Biotech, Inc60
尚未招募
1 期
A Study to Evaluate the Pharmacokinetics and Safety of IN-M00007 and IN-R00007 in Healthy Adult VolunteersNCT07311811HK inno.N Corporation60
招募中
4 期
A Study to Evaluate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of Xdivane versus Opdivo® in Patients with Resected MelanomaMelanoma2025-522307-14-00Intas Pharmaceuticals Limited19