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
NCT ID: NCT06785571
Last Updated: 2025-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
204 participants
INTERVENTIONAL
2023-08-30
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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lower loading dose of Nalbuphine hydrochloride for step 1
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)
Nalbuphine 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)
higher loading dose of Nalbuphine hydrochloride for step 1
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)
Nalbuphine 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)
Hydromorphone hydrochloride injection for step 1
Hydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h)
Hydromorphone hydrochloride injection
A maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h)
The optimal loading of Nalbuphine hydrochloride injection for step 2
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)
Nalbuphine 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)
Hydromorphone hydrochloride injection for step 2
Hydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h)
Hydromorphone hydrochloride injection
A maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h)
Interventions
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Nalbuphine 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)
Hydromorphone hydrochloride injection
A maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h)
Eligibility Criteria
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Inclusion Criteria
2. 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 Criteria
2. Living expectancy of less than 48 hours
3. Neurological disorder and any other condition interfering with sedation assessment
4. Gastrointestinal obstruction
5. Asthmatic
6. Abdominal compartment syndrome
7. Serious hepatic dysfunction (CTP 10-15)
8. Acute kidney injury (KDIGO stage 2 or 3) or Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/min/1.73m2
9. Circulatory instability (the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain proper blood pressure)
10. Need deep sedation or paralytics
11. Anticipation to receive operations (including tracheotomy)
12. Abuse of controlled substances or alcohol
13. Pregnancy, lactation, or an intention of gestation in 6 months
14. Inclusion in another interventional trial in the past 30 days
15. Other conditions deemed unsuitable to be included
18 Years
80 Years
ALL
No
Sponsors
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Yichang Humanwell Pharmaceutical Co., Ltd., China
INDUSTRY
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Locations
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Wuhan Union Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-0407
Identifier Type: -
Identifier Source: org_study_id
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