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Assessment of the Safety and Efficacy of Oliceridine in Elderly Patients Undergoing Transurethral Laser Enucleation of the Prostate under General Anesthesia: A Randomized, Double-Blind, Controlled Exploratory Study

Assessment of the Safety and Efficacy of Oliceridine in Elderly Patients Undergoing Transurethral Laser Enucleation of the Prostate under General Anesthesia: A Randomized, Double-Blind, Controlled Exploratory Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108847
Enrollment
Unknown
Registered
2025-09-08
Start date
2025-09-30
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Prostatic hyperplasia

Interventions

Experimental group:Oliceridine is used for perioperative analgesia.
Control group:Sufentanil for perioperative analgesia

Sponsors

Renjin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
70 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age: 70 years old <= age <= 90 years old; 2. Patients who are planned to undergo transurethral laser enucleation of the prostate under general anesthesia; 3. Patients participate voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Previous severe cerebrovascular accidents and other neurological disorders: such as neuroimmune diseases, central nervous system infections, movement disorders (such as Parkinson's disease, etc.), hereditary neurological diseases, developmental abnormal diseases, etc; 2. Mental disorders, long-term use of drugs affecting the function of the central nervous system, benzodiazepines or opioids; 3. History of allergy to anesthetic drugs; 4. Preoperative hypotension or preoperative SpO2 = 6 standard drinks/day); 7. Patients diagnosed with severe cardiopulmonary diseases, or respiratory system diseases or respiratory tract diseases: such as sleep apnea syndrome; 8. Bradycardia or atrioventricular block; 9. Participation in other clinical trials within 4 weeks; 10. Abnormal cognition or communication as determined by the researcher; 11. Emergent critical situations during the operation; 12. Other conditions deemed unsuitable for participation in the study by the researcher.

Design outcomes

Primary

MeasureTime frame
Time of laryngeal mask removal;

Secondary

MeasureTime frame
Adverse events during the perioperative period/PACU;The patient's hemodynamic status;Time to recovery of spontaneous breathing;Duration of stay in the Post-Anesthesia Care Unit (PACU);The incidence of postoperative hypoxia;Patient satisfaction with anesthesia and postoperative recovery/NRS score;The incidence of other adverse events during and after the operation;NRS scores at 6, 9 and 24 hours after leaving the PACU;

Countries

China

Contacts

Public ContactHui Zhu

Renjin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Zhuhui7681@163.com+86 139 1722 6020

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026