Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery

NCT07412223 | Not Yet Recruiting Phase 4

• 1 other identifier: 202601008
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Be randomly assigned to receive either a tegileridine-based or a morphine-based pain relief pump after surgery.
2. 2.Use the patient-controlled analgesia (PCA) pump for up to 72 hours postoperatively to manage their pain.
3. 3.Be assessed for the time it takes for their bowel function to return (tolerating food and having gas or bowel movement).
4. 4.Have their pain levels, overall recovery quality, sleep quality, and any side effects monitored during hospitalization.
5. 5.Be followed up 30 days after surgery.

Conditions

Pain, Postoperative; Postoperative Ileus

Keywords

Tegileridine; Postoperative Ileus; Postoperative Pain; GI-3 composite endpoint; Abdominal Surgery

Outcome Measures

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.

  Within 72 hours after abdominal surgery.

Secondary Outcomes (8)

• Time to GI-3 recovery.

  From end of surgery up to 7 days postoperatively.

• Time to first tolerance of solid food.

  From end of surgery up to 7 days postoperatively.

• Time to first flatus.

  From end of surgery up to 7 days postoperatively.

• Overall Benefit of Analgesia Score (OBAS).

  At 24, 48, and 72 hours postoperatively.

• Quality of Recovery-15 (QoR-15) Score.

  At 24 hours postoperatively.

Study Arms (2)

Tegileridine PCIA Group

EXPERIMENTAL

Drug: Tegileridine

Morphine PCIA Group

ACTIVE COMPARATOR

Drug: Morphine

Interventions

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.

Morphine PCIA Group

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.

Tegileridine PCIA Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).
• 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.
• Significant hepatic or renal dysfunction (e.g., ALT/AST \> 3 times the upper limit of normal, or requiring renal replacement therapy).
• Planned admission to the Intensive Care Unit (ICU) for postoperative management.
• Participation in another interventional clinical trial within the 3 months prior to randomization.
• Any other condition deemed by the investigator as unsuitable for participation in this trial.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Zongbin S. Song, M.D., Ph.D.

  Xiangya Hospital of Central South University

  STUDY DIRECTOR

Central Study Contacts

Longyan Li, M.D., Ph.D.

CONTACT

+86-15273139192; lilongyan206@csu.edu.cn

Lirui Xian, M.B.

CONTACT

+86-19198053454; xianlirui123@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 17, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 24, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02