Tegileridine vs Sufentanil for Postoperative Pain Management and Gastrointestinal Recovery After … (NCT07637968) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Tegileridine vs Sufentanil for Postoperative Pain Management and Gastrointestinal Recovery After Major Laparoscopic Abdominal Surgery
84 participantsStarted 2026-06-01
Plain-language summary
This study is a single-center, randomized, triple-blind clinical trial designed to compare tegileridine and sufentanil for postoperative analgesia and gastrointestinal tolerability in patients undergoing major laparoscopic abdominal surgery. Participants will be randomly assigned to receive either tegileridine or sufentanil for postoperative patient-controlled intravenous analgesia according to the study protocol. The purpose of this study is to determine whether tegileridine can provide better gastrointestinal tolerability while maintaining non-inferior postoperative pain control compared with sufentanil in this patient population.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-75 years.
* Elective major abdominal surgery as defined above.
* Body mass index (BMI) 18-30 kg/m².
* American Society of Anesthesiologists (ASA) physical status I to III.
* Written informed consent.
Exclusion Criteria:
* Known hypersensitivity to opioids or any component of the study medications.
* Clinically significant hypoxemia, such as oxygen saturation less than 90 percentage, or a history of severe asthma.
* Known or suspected gastrointestinal obstruction, including paralytic ileus.
* Pregnancy or breastfeeding.
* Severe hepatic impairment (Child-Pugh class C).
* Severe heart failure (NYHA class III-IV) or unstable arrhythmia.
* Neurological or psychiatric disorders that may interfere with pain or sedation assessment (e.g., epilepsy, impaired consciousness, uncontrolled psychiatric illness).
* History of chronic pain or long-term use of analgesics/analgesic products.
* Current use of sedative-hypnotic medications.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Curve of Resting Pain Intensity Within 24 Hours After Admission to the PACU
Timeframe: From 0 to 24 hours after admission to the PACU
Trial details
NCT IDNCT07637968
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine