Tegileridine for faster bowel recovery after abdominal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, controlled trial compares tegileridine to morphine for postoperative pain management after elective abdominal surgery. All participants receive dexmedetomidine via PCIA, and the study focuses on recovery of gastrointestinal function within 72 hours. Adults with BMI 18-30, ASA I-III, undergoing general anesthesia, are eligible, while those with GI tract surgery, advanced cancer with ascites, or certain cardiovascular conditions are excluded. The primary aim is to determine whether tegileridine improves bowel recovery and safety compared with morphine.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Scheduled to undergo elective abdominal surgery under general anesthesia.
2. Age ≥ 18 years.
3. Body Mass Index (BMI) between 18 and 30 kg/m².
4. American Society of Anesthesiologists (ASA) physical status classification of I to III.
5. Requires postoperative analgesia and is capable of correctly using a patient-controlled intravenous analgesia (PCIA) pump.
6. Understands the trial objectives and voluntarily participates, providing written informed consent.

Exclusion Criteria:

1. Undergoing gastrointestinal tract surgery.
2. Has advanced cancer with ascites or extensive metastasis, or is receiving systemic chemotherapy/radiotherapy, or requires postoperative hyperthermic intraperitoneal chemotherapy (HIPEC).
3. Diagnosed or suspected gastrointestinal obstruction or emptying disorder.
4. History of severe cardiovascular or cerebrovascular disease (e.g., severe sinus bradycardia, myocardial infarction, unstable angina, grade II or higher atrioventricular block, history of arrhythmia, NYHA class II or higher heart failure, ischemic stroke) or abnormal QTcF interval at screening ( \>450 ms for males, \>470 ms for females).
5. Comorbid psychiatric or neurological disorders (e.g., schizophrenia, depression, epilepsy) or cognitive dysfunction.
6. Known allergy to opioid drugs or any component of the trial medications.
7. Current acute or chronic pain conditions, or presence of hyperalgesia or other sensory disorders.
8. Long-term opioid therapy (defined as receiving \>15 mg morphine milligram equivalents per day for more than 3 days per week, over a period exceeding 1 month within the 12 months prior to surgery).
9. Pregnant or breastfeeding women, or those with a positive pregnancy test at screening or on the day of surgery; or participants (including males) planning for pregnancy.
10. Significant hepatic or renal dysfunction (e.g., ALT/AST \> 3 times the upper limit of normal, or requiring renal replacement therapy).
11. Planned admission to the Intensive Care Unit (ICU) for postoperative management.
12. Participation in another interventional clinical trial within the 3 months prior to randomization.
13. Any other condition deemed by the investigator as unsuitable for participation in this trial.

Where it's running

• The Third Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• Hunan Provincial Maternal and Child Health Care Hospital
  Changsha, Hunan, China Recruiting
• Xiangya hospital of Central South Univesity
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Longyan Li, M.D., Ph.D.
• Email: lilongyan206@csu.edu.cn
• Phone: +86-15273139192

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.