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A study of the safety and efficacy of oliceridine versus hydromorphone for analgesia in postoperative mechanically ventilated patients in the ICU

A study of the safety and efficacy of oliceridine versus hydromorphone for analgesia in postoperative mechanically ventilated patients in the ICU

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098125
Enrollment
Unknown
Registered
2025-03-03
Start date
2025-03-05
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

mechanical ventilation

Interventions

Experimental group:oliceridine group:Analgesic sedation with oliceridine and propofol
Control group:hydromorphone group:Analgesic sedation with hydromorphone and propofol

Sponsors

Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged 18-80 years; (2) Patients expected to be admitted to the ICU after surgery who are expected to require ventilator-assisted respiration after surgery and who have been mechanically ventilated for greater than 8h and less than 48h; (3) The need for immediate analgesic and sedative medication for comfort, safety, and to facilitate life support measures; (4) The subject or his/her authorized agent agrees and signs an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Refused to participate in this study; (2) Patients who are participating in other drugs or clinical studies; and (3) Severe hepatic insufficiency (liver function classified as Child C), acute hepatic failure, severe, pre-existing substantial liver disease with clinically significant portal hypertension; (4) Renal insufficiency requiring renal replacement therapy; (5) ICU stay >= 1 week before enrollment; mechanical ventilation >= 48 hours or less than 8 hours before enrollment; expected need for mechanical ventilation support for an excessive period of time, such as peripheral neuromuscular disease, brainstem injury, and respiratory center involvement; (6) Pregnant or lactating women; (7) Hypersensitivity to opioids or contraindications to the use of other medications: (8) Subjects assessed as needing maintenance of sedation targeting RASS scores in the range of -5 ~ -3; (9) Patients with severe craniocerebral trauma complicated by intracranial hypertension, psychiatric disorders, etc. who are unable to perform RASS score or NRS score or CPOT score; (10) Prolonged QT interval before enrollment i.e. QT interval >= 440ms; (11) Presence of factors that increase the risk associated with participation in the study (e.g., presence of severe hypotension, etc.), or the existence of potential disputes, which in the judgment of the investigator make the patient unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Time to analgesia;

Secondary

MeasureTime frame
Vital signs;

Countries

China

Contacts

Public ContactLei Xianying

Affiliated Hospital of Southwest Medical University

leixianying310@swmu.edu.cn+86 133 2074 1667

Outcome results

None listed

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