A Phase 2/3 interventional study of Nalbuphine hydrochloride injection and Hydromorphone hydrochloride injection in Respiratory Insufficiency, sponsored by Wuhan Union Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-21.
Sponsored by Wuhan Union Hospital, China · Phase 2/3, Interventional, and Treatment
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 204 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Wuhan Union Hospital, China is the lead sponsor of 230 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nalbuphine hydrochloride injection, a loading dose of 4 mg 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)
Drug: Nalbuphine hydrochloride injection
Nalbuphine hydrochloride injection, a loading dose of 6 mg 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)
Drug: Nalbuphine hydrochloride injection
Hydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h)
Drug: Hydromorphone hydrochloride injection
Nalbuphine hydrochloride injection: a loading dose determined after step 1 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)
Drug: Nalbuphine hydrochloride injection
Hydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h)
Drug: Hydromorphone hydrochloride injection
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)
The analgesic success rate
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
Time frame: Within 24 hours while receiving the study drug
The percentage of time with light sedation duration
Light sedation duration is defined as subjects with CPOT ≤ 2 points and -2 points ≤ RASS ≤ 1
Time frame: Within 24 hours while receiving the study drug
The amout of propfol used
The amout of propfol used
Time frame: Within 24 hours while receiving the study drug
Successful extubation
Successful extubated without reintubation
Time frame: Within 24 hours while receiving the study drug
Cmax
peak plasma concentration
Time frame: Within 24 hours while receiving the study drug
The area under the plasma drug concentration-time curve
The area under the plasma drug concentration-time curve (AUC)
Time frame: Within 24 hours while receiving the study drug
t1/2
half-life
Time frame: Within 24 hours while receiving the study drug
Plan to share: No
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Wuhan Union Hospital, China