Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery (NCT07412223) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
152 participantsStarted 2026-02-24
Plain-language summary
Title: Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery: A Multicenter, Randomized, Controlled Trial
The goal of this clinical trial is to evaluate the effectiveness and safety of tegileridine, a biased μ-opioid receptor agonist, for patient-controlled intravenous analgesia (PCIA) after abdominal surgery.
The main question it aims to answer is:
Is tegileridine superior to morphine in promoting the recovery of gastrointestinal function within 72 hours after abdominal surgery?
Researchers will compare the experimental group (receiving Fumarate Tegileridine Injection) to the active control group (receiving Morphine Hydrochloride Injection). Both groups will also receive dexmedetomidine in their PCIA pumps. This comparison will determine if tegileridine is more effective for bowel recovery and has a better safety profile.
Participants who are scheduled for elective abdominal surgery under general anesthesia will:
1. Be randomly assigned to receive either a tegileridine-based or a morphine-based pain relief pump after surgery.
2. Use the patient-controlled analgesia (PCA) pump for up to 72 hours postoperatively to manage their pain.
3. Be assessed for the time it takes for their bowel function to return (tolerating food and having gas or bowel movement).
4. Have their pain levels, overall recovery quality, sleep quality, and any side effects monitored during hospitalization.
5. Be followed up 30 days after surgery.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Scheduled to undergo elective abdominal surgery under general anesthesia.
✓. Age ≥ 18 years.
✓. Body Mass Index (BMI) between 18 and 30 kg/m².
✓. American Society of Anesthesiologists (ASA) physical status classification of I to III.
✓. Requires postoperative analgesia and is capable of correctly using a patient-controlled intravenous analgesia (PCIA) pump.
✓. Understands the trial objectives and voluntarily participates, providing written informed consent.
Exclusion criteria
✕. Undergoing gastrointestinal tract surgery.
✕. Has advanced cancer with ascites or extensive metastasis, or is receiving systemic chemotherapy/radiotherapy, or requires postoperative hyperthermic intraperitoneal chemotherapy (HIPEC).
✕. Diagnosed or suspected gastrointestinal obstruction or emptying disorder.
What they're measuring
1
Proportion of participants with recovery of gastrointestinal function within 72 hours post-surgery.
Timeframe: Within 72 hours after abdominal surgery.
Trial details
NCT IDNCT07412223
SponsorXiangya Hospital of Central South University
. 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).
✕. Comorbid psychiatric or neurological disorders (e.g., schizophrenia, depression, epilepsy) or cognitive dysfunction.
✕. Known allergy to opioid drugs or any component of the trial medications.
✕. Current acute or chronic pain conditions, or presence of hyperalgesia or other sensory disorders.
✕. 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).