Elective laparoscopic abdominal surgery in elderly patients
Conditions
Interventions
Group Oliceridine:oliceridine 0.3 mg/kg
Group Tegileridine: Tegileridine0.1 mg/kg
Sponsors
Cangzhou Central Hosptial
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age 65–85 years, regardless of gender; 2. Scheduled for elective laparoscopic abdominal surgery (including laparoscopic cholecystectomy and radical resection for colorectal cancer); 3. American Society of Anesthesiologists (ASA) physical status classification II–III; 4. The patient and their legal representative have been fully informed and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to oliceridine, tegileridine, or any of their excipients; 2. History of opioid abuse or dependence; 3. Use of opioid analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), or other medications that may affect pain assessment within 1 week prior to surgery; 4. Severe respiratory diseases (e.g., acute exacerbation of chronic obstructive pulmonary disease, status asthmaticus); 5. Severe cardiovascular diseases (e.g., congestive heart failure, uncontrolled hypertension, or arrhythmia); 6. Abnormal QTcF interval: >450 ms in males or >470 ms in females; 7. Severe hepatic or renal insufficiency (Child-Pugh class C liver function; eGFR <30 ml/min/1.73m²); 8. Suspected gastrointestinal obstruction, including paralytic ileus; 9. History of psychiatric disorders, cognitive impairment, or inability to express pain accurately; 10. Pregnant or lactating women; 11. Concurrent participation in other clinical trials; 12. Other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement rate of pain score control at 48 h after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Numerical rating scale,NRS;The times and proportion of rescue analgesic medication use within 48 hours after surgery;Total analgesic consumption within 48 h after surgery;Incidence of respiratory depression in the PACU;Incidence of postoperative nausea and vomiting (PONV) within 48 h after surgery;Hemodynamic parameters in the PACU;Length of stay in the Post-Anesthesia Care Unit (PACU);Time to first postoperative ambulation and gastrointestinal function recovery;QoR-15;Length of hospital stay; | — |
Countries
China
Contacts
Public ContactWenbo Sun
Cangzhou Central Hosptial
Outcome results
None listed