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The Evaluation of the Effectiveness and Safety of Nalbuphine Hydrochloride Injection for Analgesia in ICU Patients: A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial

ConditionRespiratory Insufficiency
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ICU patients who are intubated are expected to require mechanical ventilation for more than 6h

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

Disqualifiers

Allergy or unsuitability to any composition of study drugs or propofol

Living expectancy of less than 48 hours

Neurological disorder and any other condition interfering with sedation assessment

Gastrointestinal obstruction

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nalbuphine hydrochloride injection

    Drug

    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)

  • Hydromorphone hydrochloride injection

    Drug

    A maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h)

Treatment groups

204 Participants
are divided into 5 treatment groups
Group A: lower loading dose of Nalbuphine hydrochloride for step 1Experimental treatment 1 intervention
Group B: higher loading dose of Nalbuphine hydrochloride for step 1Experimental treatment 1 intervention
Group C: Hydromorphone hydrochloride injection for step 1Active comparator 1 intervention
Group D: The optimal loading of Nalbuphine hydrochloride injection for step 2Experimental treatment 1 intervention
Group E: Hydromorphone hydrochloride injection for step 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

The amout of propfol used

The amout of propfol used

Time frame
Within 24 hours while receiving the study drug
3

Successful extubation

Successful extubated without reintubation

Time frame
Within 24 hours while receiving the study drug

Other outcomes

1

Cmax

peak plasma concentration

Time frame
Within 24 hours while receiving the study drug
2

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
3

t1/2

half-life

Time frame
Within 24 hours while receiving the study drug

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Lead sponsor

Yichang Humanwell Pharmaceutical Co., Ltd., China

Collaborator

Source ClinicalTrials.gov
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