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Efficacy and safety of oxycodone hydrochloride and remifentanil for long-term analgesia during invasive mechanical ventilation in postoperative patients: A Pilot study

Efficacy and safety of oxycodone hydrochloride and remifentanil for long-term analgesia during invasive mechanical ventilation in postoperative patients: A Pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092502
Enrollment
Unknown
Registered
2024-11-18
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

intubated

Interventions

Test group:Oxycodone Hydrochloride Injection continuous infusion therapy was administered
Control group:Remifentanil Injection continuous infusion was administered

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) 18 = 24 hours;

Exclusion criteria

Exclusion criteria: 1) Patients requiring deep sedation (e.g., severe human-machine asynchrony in mechanically ventilated patients, respiratory distress due to severe respiratory failure, use of neuro-muscular blocking agents, status epilepticus, postoperative surgery requiring strict immobilization, hypothermia treatment, etc.); 2) Chronic kidney disease, severe liver dysfunction (Child-Pugh grade C); 3) severe shock requiring norepinephrine =0.5 µg/kg/min; 4) American Society of Anesthesiologists (ASA) classification class 5 patients (near death); 5) Nerve damage or organic pathological changes in the brain; 6) Requires a specified sedative or anesthetic other than the study drug during treatment; 7) patients with chronic pain, often using strong opioids, such as morphine; 8) history of alcohol or drug abuse; 9) Participation in other opioid investigations within 30 days; 10) Pregnant or lactating women; 11) Patients with allergies and contraindications to the study drug; 12) Patients judged by the investigator to be unsuitable for inclusion in the study;

Design outcomes

Primary

MeasureTime frame
Percentage of time with CPOT < 3 without rescue analgesia within 7 days of mechanical ventilation;

Secondary

MeasureTime frame
Days without mechanical ventilation within 28 days;Change in gastrointestinal function within 7 days of dosing;Ventilator-associated pneumonia;AE;Successful extubation rate within 28 days;Los;Delirium;

Countries

China

Contacts

Public ContactZhong Ming

Zhongshan Hospital, Fudan University

zhong.ming@zs-hospital.sh.cn+86 21 64041990

Outcome results

None listed

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