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NCT07637968
Tegileridine vs Sufentanil for Postoperative Pain Management and Gastrointestinal Recovery After Major Laparoscopic Abdominal Surgery
Conditions: Postoperative Pain
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 84
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07637968). StuddyBuddy aggregates publicly available trial information.