Respiratory Insufficiency
Conditions
Brief summary
The analgesic effect of nalbuphine hydrochloride injection will be evaluated in a multicenter, randomized, single-blind, parallel, positive-controlled approach in two steps: step 1, to explore the optimal dosage of nalbuphine hydrochloride injection with 2 experimental arms and 1 positive control and step 2, to evaluate the effectiveness and safety of nalbuphine hydrochloride injection in mechanically ventilated ICU patients at a dosage determined in step 1 with the same positive control.
Interventions
a loading dose of Nalbuphine hydrochloride injection administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0\ 5.0mg/h)
A maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\ 3.0mg/h)
Sponsors
Yichang Humanwell Pharmaceutical Co., Ltd., China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. ICU patients who are intubated are expected to require mechanical ventilation for more than 6h 2. patients or their guardians have a full understanding of the purpose and significance of this trial, and voluntarily participate in this clinical trial and sign an informed consent form
Exclusion criteria
1. Allergy or unsuitability to any composition of study drugs or propofol 2. Living expectancy of less than 48 hours 3. Neurological disorder and any other condition interfering with sedation assessment 4. Gastrointestinal obstruction 5. Asthmatic 6. Abdominal compartment syndrome 7. Serious hepatic dysfunction (CTP 10-15) 8. Acute kidney injury (KDIGO stage 2 or 3) or Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/min/1.73m2 9. Circulatory instability (the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain proper blood pressure) 10. Need deep sedation or paralytics 11. Anticipation to receive operations (including tracheotomy) 12. Abuse of controlled substances or alcohol 13. Pregnancy, lactation, or an intention of gestation in 6 months 14. Inclusion in another interventional trial in the past 30 days 15. Other conditions deemed unsuitable to be included
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The analgesic success rate | Within 24 hours while receiving the study drug | The analgesic success is determined as 1) no use of rescue analgesic medication and 2) at least 70% of the time with CPOT ≤ 2 points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of time with light sedation duration | Within 24 hours while receiving the study drug | Light sedation duration is defined as subjects with CPOT ≤ 2 points and -2 points ≤ RASS ≤ 1 |
| Successful extubation | Within 24 hours while receiving the study drug | Successful extubated without reintubation |
| The amout of propfol used | Within 24 hours while receiving the study drug | The amout of propfol used |
Other
| Measure | Time frame | Description |
|---|---|---|
| t1/2 | Within 24 hours while receiving the study drug | half-life |
| Cmax | Within 24 hours while receiving the study drug | peak plasma concentration |
| The area under the plasma drug concentration-time curve | Within 24 hours while receiving the study drug | The area under the plasma drug concentration-time curve (AUC) |
Countries
China
Contacts
Primary Contactyou shang
Outcome results
None listed