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ED50 of Oxycodone-Propofol Combination in Inhibiting Intraoperative Body Movement in Elderly Patients Undergoing Prostate Biopsy

ED50 of Oxycodone-Propofol Combination in Inhibiting Intraoperative Body Movement in Elderly Patients Undergoing Prostate Biopsy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129617
Enrollment
Unknown
Registered
2026-08-07
Start date
2026-08-10
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Prostate Cancer

Interventions

Oxycodone Group:Based on relevant literature on the use of oxycodone for sedation in elderly patients, the initial dose of oxycodone was set at 15 µg/kg. The dose for the next patient was determined u
Grade 2 (involuntary limb movement that interfered with the procedure and required additional anesthetics)
Grade 3 (agitation with complete inability to cooperate, requiring procedure termination and resumption after deepening anesthesia). If a positive response affecting the surgical procedure occurred, t
otherwise, it was decreased by one gradient. The adjacent dose gradient was 1.5 µg/kg. A dose crossover point was recorded when a "positive response converted to a negative response" or vice versa. Th

Sponsors

Union Hospital Affiliated to Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male patients aged >= 65 years scheduled for prostate biopsy; 2. American Society of Anesthesiologists (ASA) physical status classification ?-?; 3. Body Mass Index (BMI) ranging from 18.5 to 24 kg/m²; 4. Voluntary participation in the study and signing of the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergy to oxycodone, propofol, or other opioid drugs; 2. Presence of severe cardiovascular and cerebrovascular diseases (e.g., unstable angina pectoris, myocardial infarction, severe arrhythmia, acute phase of stroke, etc.); 3. Severe liver or kidney dysfunction (e.g., Child-Pugh class C liver function, creatinine clearance rate < 30 ml/min); 4. Expected difficult airway, obstructive sleep apnea syndrome, myasthenia gravis, or other diseases affecting respiration; 5. Known or suspected gastrointestinal obstruction (e.g., paralytic ileus); 6. History of mental illness, drug abuse, or alcohol abuse; 7. Long-term use of opioid drugs or other medications affecting pain perception; 8. Participation in other clinical studies within 1 month; 9. Patients deemed inappropriate to participate by the researchers.

Design outcomes

Primary

MeasureTime frame
ED?? of oliceridine combined with propofol for suppressing body?movement response in elderly patients undergoing prostate biopsy;

Secondary

MeasureTime frame
Sedation score at immediate emergence from anesthesia;NRS score at 0.5 h after emergence from anesthesia;Perioperative adverse reactions;

Countries

China

Contacts

Public ContactXiuru Chen

Union Hospital Affiliated to Fujian Medical University

1047693755@qq.com+86 182 5046 7044

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026