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Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery

ConditionsPain, PostoperativePostoperative Ileus
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorXiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tegileridine

    Drug

    Participants in this arm will receive postoperative analgesia via a Patient-Controlled Intravenous Analgesia (PCIA) pump containing a sterile solution. The pump is filled with a 100 mL mixture of the investigational drug, Tegileridine Fumarate Injection, at a concentration of 0.05 mg/mL, and the adjuvant drug, Dexmedetomidine Hydrochloride Injection, at 2 μg/mL. The PCA pump is programmed with no continuous background infusion (0 mL/h). A loading dose of 20 mL is administered at the start. Thereafter, participants can self-administer a 4 mL bolus on-demand for pain relief, with a maximum allowable dose of 12 mL per hour and a lockout interval of 10 minutes between boluses. This intervention is planned for a duration of 72 hours following abdominal surgery.

  • Morphine

    Drug

    Participants in this arm will receive postoperative analgesia via a Patient-Controlled Intravenous Analgesia (PCIA) pump containing a sterile solution. The pump is filled with a 100 mL mixture of the active comparator drug, Morphine Hydrochloride Injection, at a concentration of 0.25 mg/mL, and the same adjuvant drug, Dexmedetomidine Hydrochloride Injection, at 2 μg/mL. The PCA pump parameters are identical to Arm 1: no continuous background infusion (0 mL/h), a 20 mL loading dose, a 4 mL on-demand bolus dose, a maximum limit of 12 mL per hour, and a 10-minute lockout interval. This intervention is also planned for a duration of 72 hours post-surgery. The sole distinction between the two arms is the core analgesic agent (Tegileridine vs. Morphine) within the otherwise identical PCIA regimen.

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: Tegileridine PCIA GroupExperimental treatment 1 intervention
Group B: Morphine PCIA GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with recovery of gastrointestinal function within 72 hours post-surgery.

Gastrointestinal function recovery is defined by the GI-3 composite endpoint: the ability to tolerate solid food (time to first tolerance of solid food) AND having either flatus (time to first flatus) or bowel movement (time to first bowel movement). The proportion is calculated as the number of participants who meet this composite endpoint within 72 hours after surgery divided by the total number of participants analyzed.

Time frame
Within 72 hours after abdominal surgery.

Secondary outcomes

1

Time to GI-3 recovery.

The time (in hours) from the end of surgery until the participant first meets the GI-3 composite endpoint (tolerating solid food AND having flatus or bowel movement).

Time frame
From end of surgery up to 7 days postoperatively.
2

Time to first tolerance of solid food.

The time (in hours) from the end of surgery until the participant first tolerates solid food.

Time frame
From end of surgery up to 7 days postoperatively.
3

Time to first flatus.

The time (in hours) from the end of surgery until the participant has the first passage of flatus.

Time frame
From end of surgery up to 7 days postoperatively.
4

Overall Benefit of Analgesia Score (OBAS).

The OBAS is a composite score (range 0-28) assessing pain at rest, opioid-related side effects (vomiting, pruritus, sweating, shivering, dizziness), and satisfaction with analgesia. A lower score indicates a higher overall benefit. It will be assessed at 24h, 48h, and 72h postoperatively.

Time frame
At 24, 48, and 72 hours postoperatively.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiangya Hospital of Central South University

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Collaborator

Hunan Provincial Maternal and Child Health Care Hospital

Collaborator

Source ClinicalTrials.gov
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