Tegileridine Versus Sufentanil for Postoperative Analgesia and Gastrointestinal Tolerability After Major Laparoscopic Abdominal Surgery: A Single-Center, Randomized, Triple-Blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
研究概览
简要总结
This study is a single-center, randomized, triple-blind clinical trial designed to compare tegileridine and sufentanil for postoperative analgesia and gastrointestinal tolerability in patients undergoing major laparoscopic abdominal surgery. Participants will be randomly assigned to receive either tegileridine or sufentanil for postoperative patient-controlled intravenous analgesia according to the study protocol. The purpose of this study is to determine whether tegileridine can provide better gastrointestinal tolerability while maintaining non-inferior postoperative pain control compared with sufentanil in this patient population.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, care providers, and outcomes assessors will be blinded to group allocation. Study drugs will be prepared and labeled by personnel not involved in postoperative care or outcome assessment to maintain blinding.
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.
- •Elective major abdominal surgery as defined above.
- •Body mass index (BMI) 18-30 kg/m².
- •American Society of Anesthesiologists (ASA) physical status I to III.
- •Written informed consent.
排除标准
- •Known hypersensitivity to opioids or any component of the study medications.
- •Clinically significant hypoxemia, such as oxygen saturation less than 90 percentage, or a history of severe asthma.
- •Known or suspected gastrointestinal obstruction, including paralytic ileus.
- •Pregnancy or breastfeeding.
- •Severe hepatic impairment (Child-Pugh class C).
- •Severe heart failure (NYHA class III-IV) or unstable arrhythmia.
- •Neurological or psychiatric disorders that may interfere with pain or sedation assessment (e.g., epilepsy, impaired consciousness, uncontrolled psychiatric illness).
- •History of chronic pain or long-term use of analgesics/analgesic products.
- •Current use of sedative-hypnotic medications.
研究者
Jihong Jiang
Professor, Department of Anesthesiology
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine