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Not yet recruitingNCT07844512Updated Sep 28, 2026

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

A Phase 3 interventional study of Tegileridine (tegileridine fumarate injection, IV) and Sufentanil in Pain Management, Overweight , Obesity and Respiration; Sleep Disorder, sponsored by The First Hospital of Jilin University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by The First Hospital of Jilin University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pain Management
  • Overweight , Obesity
  • Respiration; Sleep Disorder
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
148 participants (estimated)

Study arms

  • Experimental
    Tegileridine Group

    Drug: Tegileridine (tegileridine fumarate injection, IV)

  • Active comparator
    Standard Opioid Group

    Drug: Sufentanil

Interventions

  • DrugTegileridine (tegileridine fumarate injection, IV)

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

  • DrugSufentanil

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

05

What researchers measure

Primary outcomes

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

    Time frame: 24 hours after bariatric surgery

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 41365300 ↗
  • 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. PubMed 40049186 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07844512
Lead sponsor
The First Hospital of Jilin University
Responsible party
Sponsor
First posted
Sep 28, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Sep 28, 2026

Study contacts

Meikun Wang, MD
Contact
wangmkjdyy@jlu.edu.cn
+8613578774973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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