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.
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
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
Parallel
Tegileridine (tegileridine fumarate injection, IV)
DrugTegileridine will be given to participants for postoperative pain relief after bariatric surgery.
Sufentanil
DrugSufentanil, a standard opioid analgesic, will be given to participants to manage postoperative pain following bariatric surgery.
Quality of Recovery-15 (QoR-15) Score at 24 Hours After Surgery
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This trial is not recruiting at the moment. You can still explore other options:
