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The Application of Oliceridine Fumarate in perioperative multimodal analgesia after renal transplant surgery: a single-center, randomized, double-blind, positive controlled trial

The Application of Oliceridine Fumarate in perioperative multimodal analgesia after renal transplant surgery: a single-center, randomized, double-blind, positive controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091724
Enrollment
Unknown
Registered
2024-11-01
Start date
2024-11-01
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Interventions

Oliceridine group (O group):Patient-controlled intravenous analgesia with oliceridine
Sufentanil group (C group):Patient-controlled intravenous analgesia with sufentanil

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing allogeneic renal transplantation surgery at our hospital (usually emergency and open-abdomen surgery) with an unlimited duration of surgery; 2. Age 18-65 years old, gender is not limited; 3. 18kg/m^2<BMI<30kg/m^2; 4. Those who are fully informed of the relevant content of the clinical trial, voluntarily join and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing multi-organ transplantation surgery; 2. Previous history of other organ transplantation surgery; 3. Patients who underwent unplanned secondary surgery after kidney transplantation; 4. Patients with severe diseases, such as chronic liver disease and cardiac insufficiency; 5. Those who have a history of alcohol abuse within the previous 2 years, that is, those who drink more than 14 units of alcohol per week (360mL beer/45mL alcohol with a 40% alcohol content/150mL wine with a 1 unit alcohol content) or have acute alcohol intoxication or alcohol dependence; 6. Patients with a history of opioid allergy or long-term oral opioid use; 7. History of severe postoperative nausea and vomiting; 8. History of mental illness such as schizophrenia; 9. Those who are judged to lack the ability to give informed consent or fail to sign the informed consent; 10. Patients who refused to participate further during the follow-up period;

Design outcomes

Primary

MeasureTime frame
The effective rate of PCIA analgesia in 24h after operation;

Secondary

MeasureTime frame
NRS scores and cumulative AUC at 6 time points within 48 hours after surgery, maximum pain intensity within 48 hours, first PCA time, number of effective PCA compressions, and dosage of remedial analgesics;The incidence of opioid-related adverse complications (dizziness, drowsiness, nausea, vomiting, respiratory depression, hypoxemia, etc.) within 48 hours after surgery;The use of antiemetic drugs within 48 hours after surgery;Satisfaction with analgesia at 48h after surgery;Changes in renal function evaluation, inflammatory factors, and postoperative immune indicators 7 days after surgery;Quality of recovery at 1 day and 3 days after surgery;

Countries

China

Contacts

Public ContactYaomin Zhu

The First Affiliated Hospital of Xi'an Jiaotong University

zhuyaomin_mzk@163.com+86 18629382846

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 11, 2026