Actively Recruiting
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
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-01-21
204
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
Y
Yichang Humanwell Pharmaceutical Co., Ltd., China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ICU patients who are intubated and expected to require mechanical ventilation for more than 6 hours
- Patients or their guardians understand the trial purpose and voluntarily agree to participate by signing informed consent
You will not qualify if you...
- Allergy or unsuitability to any study drugs or propofol
- Life expectancy less than 48 hours
- Neurological disorders or conditions affecting sedation assessment
- Gastrointestinal obstruction
- Asthma
- Abdominal compartment syndrome
- Serious liver dysfunction (Child-Turcotte-Pugh score 10-15)
- Acute kidney injury (KDIGO stage 2 or 3) or chronic kidney disease with GFR below 29 ml/min/1.73m2
- Circulatory instability requiring norepinephrine infusion at 20.5 ug/kg/min
- Need for deep sedation or paralytics
- Planned operations including tracheotomy
- Abuse of controlled substances or alcohol
- Pregnancy, lactation, or intention to become pregnant within 6 months
- Participation in another interventional trial within the past 30 days
- Other conditions deemed unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
Y
you shang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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