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Efficacy and safety of nalbuphine combined with hydromorphone for analgesia in patients with mechanical ventilation in ICU

Efficacy and safety of nalbuphine combined with hydromorphone for analgesia in patients with mechanical ventilation in ICU

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072198
Enrollment
Unknown
Registered
2023-06-06
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Analgesia in patients with mechanical ventilation in ICU

Interventions

Nabulphine combined with hydromorphone group:Nabulphine with hydromorphone for analgesia
Hydromorphone group:hydromorphone for analgesia

Sponsors

Union Jiangbei Hospital,Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age =18 years and =80 years; 2) Patients with mechanical ventilation who are expected to stay in ICU for more than 48 hours; 3) Moderate to severe pain requiring analgesic drugs; 4) Obtain informed consent from patients or family members.

Exclusion criteria

Exclusion criteria: 1) Under 18 years of age, or over 80 years of age; 2) pregnancy or lactation; 3) Patients undergoing surgery under general anesthesia within 48 hours; 4) Severe, pre-existing substantial liver disease with clinically significant portal hypertension, Child-Pugh grade C cirrhosis, or acute liver failure; 5) Patients with hemodynamic instability, systolic blood pressure (SBP) 15µg/kg/min, norepinephrine >15ug/min) are required; 6) Long-term use of narcotic analgesics, hypnotics and psychotropic drugs 7) Patients with severe craniocerebral injury, brain tumor, and increased intracranial pressure are prone to respiratory depression; 8) Patients with a history of alcohol or drug abuse; 9) Any conditions that interfere with the correct assessment of cognitive function, such as speech and sensory disorders or psychiatric disorders (dyspnea or organic mental dysfunction); 10) Failure to obtain informed consent or authorization; 11) Participate in other exploratory clinical trials within 6 months prior to screening; 12) Allergic reaction to the experimental drug.

Design outcomes

Primary

MeasureTime frame
The percentage of time that reached the target analgesic score range at all time points during drug administration was studied;

Secondary

MeasureTime frame
RASS score at each time point;Vital signs (MAP, SBP, HR, RR, SPO2);Occurrence and treatment of adverse events;Delirium incidence;Dosage of analgesic and sedative drugs in two groups;Mechanical ventilation time;Length of stay in ICU;

Countries

China

Contacts

Public ContactJun Guo

Union Jiangbei Hospital,Huazhong University of Science and Technology

625246269@qq.com+86 189 0863 6226

Outcome results

None listed

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