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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
204
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)
Wuhan Union Hospital
Wuhan, Hubei, China
RECRUITINGThe 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
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