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Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Recruitment opened
    • Trial sites expanded: 0 → 3 locations
    • Secondary endpoints: 8 to 9
    • Collaborators expanded, about 14 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07412223
Lead Sponsor Xiangya Hospital of Central South University
Collaborators: Third Affiliated Hospital, Sun Yat-Sen University, Hunan Provincial Maternal and Child Health Care Hospital
Conditions
(from sponsor)		 Pain, Postoperative, Postoperative Ileus
Related terms Postoperative Pain
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov