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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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).