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Study on the Dose-Response Relationship of Respiratory Depression Induced by Single Bolus Injection of Sevoflurane Combined with Oliceridine in Elderly Patients: A Randomized, Double-Blind, Controlled Trial Protocol

Study on the Dose-Response Relationship of Respiratory Depression Induced by Single Bolus Injection of Sevoflurane Combined with Oliceridine in Elderly Patients: A Randomized, Double-Blind, Controlled Trial Protocol

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114192
Enrollment
Unknown
Registered
2025-12-09
Start date
2025-12-20
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Intraoperative Pain

Interventions

the oliceridine group 1:Via microinfusion pump, a single intravenous bolus of oxycodone at doses of 0.005 mg/kg
the morphine group:Single intravenous bolus injection of morphine at doses of 0.05 mg/kg
the oliceridine group 2:A single intravenous bolus injection of 0.01 mg/kg oxycodone was administered via a microinfusion pump over 60 seconds.
the oliceridine group 3:A single intravenous bolus injection of 0.015 mg/kg oxycodone was administered via a microinfusion pump over 60 seconds.
the oliceridine group 4:A single intravenous bolus injection of 0.02 mg/kg oxycodone was administered via a microinfusion pump over 60 seconds.
the oliceridine group 5:A single intravenous bolus injection of 0.025 mg/kg oxycodone was administered via a microinfusion pump over 60 seconds.

Sponsors

The Second Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: 65–80 years old 2. Physical condition: ASA classification I–III 3. BMI: 19–35 kg/m² 4. Respiratory function: No history of chronic obstructive pulmonary disease or sleep apnoea syndrome 5. Hepatic and renal function: Serum creatinine, ALT/AST within normal range 6. No use of opioid medications or sedatives (e.g., benzodiazepines, gabapentin derivatives) within 24 hours prior to surgery. 7. Informed consent: Voluntary participation and signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergy to oxycodone or opioid medications 2. Presence of severe cardiac conditions (e.g., recent myocardial infarction, arrhythmia) or neuromuscular disorders (e.g., myasthenia gravis) 3. Special populations: Individuals with chronic alcohol consumption or smoking habits (may affect drug metabolism) 4. Recent acute upper respiratory tract infection (within 1 month) or other conditions potentially affecting respiratory function 5. Patients with psychiatric disorders rendering them unable to cooperate with the trial 6. Patients and/or their families refusing to participate in the study

Design outcomes

Primary

MeasureTime frame
Minute Ventilation;

Secondary

MeasureTime frame
Duration of Transcutaneous Oxygen Saturation (TcSO?) < 92% ;Minimum Transcutaneous Oxygen Saturation;Magnitude of Increase in Partial Pressure of End-Tidal Carbon Dioxide (PetCO?);Duration of Partial Pressure of End-Tidal Carbon Dioxide (PetCO?) Exceeding 50 mmHg;Tidal Volume;Respiratory Rate;

Countries

China

Contacts

Public ContactJian Feng Ma

The Second Affiliated Hospital of Wenzhou Medical University

fengmmman@163.com+86 138 6862 9898

Outcome results

None listed

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