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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
204 participants
Aug 30, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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
Exclusion Criteria15
- 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
- Asthmatic
- Abdominal compartment syndrome
- Serious hepatic dysfunction (CTP 10-15)
- Acute kidney injury (KDIGO stage 2 or 3) or Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/min/1.73m2
- Circulatory instability (the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain proper blood pressure)
- Need deep sedation or paralytics
- Anticipation to receive operations (including tracheotomy)
- Abuse of controlled substances or alcohol
- Pregnancy, lactation, or an intention of gestation in 6 months
- Inclusion in another interventional trial in the past 30 days
- Other conditions deemed unsuitable to be included
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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)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06785571