Postoperative Pain
Conditions
Interventions
Tigilidine group:In the tigilidine group, the PCIA solution will contain tigilidine 5 mg plus palonosetron 0.5 mg, diluted with 0.9% normal saline to a total volume of 100 mL.
Sufentanil group:In the sufentanil group, the PCIA solution will contain sufentanil 100 µg plus palonosetron 0.5 mg, diluted with 0.9% normal saline to a total volume of 100 mL.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18–75 years undergoing elective laparoscopic-assisted major abdominal surgery (defined as procedures performed under general anesthesia with an expected duration >=2 hours and requiring intensive postoperative analgesia). These include, but are not limited to: subtotal or total gastrectomy, radical resection of colorectal cancer, pancreaticoduodenectomy, hepatectomy, radical resection of cholangiocarcinoma, radical hysterectomy, and cytoreductive surgery for ovarian cancer. 2. Body mass index (BMI) between 18 and 30 kg/m². 3. American Society of Anesthesiologists (ASA) physical status classification I–III. 4. Participants who have provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with a known allergy to opioids or any components of the study drugs. 2. Patients with severe respiratory depression (e.g., oxygen saturation <90%) or a history of severe asthma. 3. Patients with known or suspected gastrointestinal obstruction (including paralytic ileus). 4. Pregnant or breastfeeding women. 5. Patients with severe hepatic impairment (Child–Pugh class C). 6. Patients with severe cardiac insufficiency (New York Heart Association [NYHA] class III–IV) or unstable arrhythmias. 7. Patients with neurological disorders that may affect pain or sedation assessment (e.g., epilepsy, impaired consciousness, uncontrolled psychiatric disorders). 8. Patients with a history of chronic pain or long-term use of analgesics/analgesic products. 9. Patients currently using sedative–hypnotic medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative pain intensity at rest within the first 24 hours postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal tolerance and functional recovery; | — |
Countries
China
Contacts
Public ContactJihong Jiang
Shanghai General Hospital
Outcome results
None listed