Safety and Analgesic Efficacy of the Biased μ-Opioid Receptor Agonist Tegileridine for Post-Operative Analgesia in Patients Undergoing Bariatric Surgery

NCT07844512 | Not Yet Recruiting Phase 3

• 1 other identifier: 2026-HS-0043
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief Summary

This single-center, stratified randomized double-blind trial tests tegileridine, a new pain drug, for pain relief after weight-loss surgery. Researchers will compare tegileridine with standard opioid pain medicine. Eligible patients having bariatric surgery will be randomly assigned to one of the two treatment groups. Patients and study teams will not know which treatment each participant receives. Participants will be grouped based on whether they have obstructive sleep apnea (OSA). The primary measurement is postoperative recovery quality in the first 24 hours after surgery using the QoR-15 survey. The study will also track pain scores, rescue pain medication use, and drug side effects for 7 days after surgery. There is no guaranteed benefit for participants. Study pain medicines may cause side effects. Doctors will provide rescue treatment for uncontrolled pain.

Conditions

Pain Management; Overweight , Obesity; Respiration; Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery-15 (QoR-15) Score at 24 Hours After Surgery

  24 hours after bariatric surgery

Study Arms (2)

Tegileridine Group

EXPERIMENTAL

Drug: Tegileridine (tegileridine fumarate injection, IV)

Standard Opioid Group

ACTIVE COMPARATOR

Drug: Sufentanil

Interventions

Tegileridine (tegileridine fumarate injection, IV) DRUG

Tegileridine will be given to participants for postoperative pain relief after bariatric surgery.

Tegileridine Group

Sufentanil DRUG

Sufentanil, a standard opioid analgesic, will be given to participants to manage postoperative pain following bariatric surgery.

Standard Opioid Group

Eligibility Criteria

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

You may qualify if:

• Age 18 to 65 years old
• Scheduled for elective bariatric surgery
• American Society of Anesthesiologists (ASA) physical status I, II or III
• Able to understand and complete the QoR-15 questionnaire
• Provide written informed consent to participate in the study

You may not qualify if:

• Known allergy or hypersensitivity to opioids, tegileridine or sufentanil
• Severe hepatic or renal dysfunction
• Preoperative chronic opioid use
• History of severe respiratory disease except obstructive sleep apnea
• Pregnant or breastfeeding women
• Participants who cannot complete postoperative follow-up
• Participation in another interventional clinical trial within 30 days before surgery

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Related Publications (2)

• Wang T, Wang Y, Xie H, Wu Z, Yu S, Ou Y, Xu M, Jiang W, Ge L, Gao J, Wang Q, Gao H, Huang Y, Zhao P, Yu Y, Huang H, Ren J, Xia Z, Zhang J, Yu J, Chen X. Tegileridine for moderate-to-severe acute pain following abdominal surgery: A randomized, double-blind, phase 3 clinical trial. Cell Rep Med. 2025 Dec 16;6(12):102477. doi: 10.1016/j.xcrm.2025.102477. Epub 2025 Dec 8.

  PMID: 41365300 RESULT

• GBD 2021 Adult BMI Collaborators. Global, regional, and national prevalence of adult overweight and obesity, 1990-2021, with forecasts to 2050: a forecasting study for the Global Burden of Disease Study 2021. Lancet. 2025 Mar 8;405(10481):813-838. doi: 10.1016/S0140-6736(25)00355-1. Epub 2025 Mar 3.

  PMID: 40049186 RESULT

MeSH Terms

Conditions

Agnosia; Overweight; Obesity; Respiratory Aspiration; Sleep Wake Disorders

Interventions

Sufentanil

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Mental Disorders

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Meikun Wang, MD

CONTACT

+8613578774973; wangmkjdyy@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: September 22, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share