Safety and Analgesic Efficacy of the Biased μ-Opioid Receptor Agonist Tapentadol in Patients Undergoing Bariatric Surgery
| Registry | NCT07844512 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 148 (Estimated) |
| Sponsor | The First Hospital of Jilin University (Other) |
| Conditions | Pain Management, Overweight , Obesity, Respiration; Sleep Disorder |
| Interventions | Tegileridine (tegileridine fumarate injection, IV), Sufentanil (Drug) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-10-01 (estimated), completion 2027-10-01 (estimated), first posted 2026-09-28, last updated 2026-10-16 |
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All trials for Pain Management All trials for Overweight , Obesity All trials of Tegileridine (tegileridine fumarate injection, IV) All trials of Sufentanil
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Tegileridine Group | Experimental | Drug: Tegileridine (tegileridine fumarate injection, IV) | |
| Standard Opioid Group | Active comparator | Drug: Sufentanil |
Sex: All, ages: 18 Years to 65 Years
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: * 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