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Recruiting NCT06785571

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

Phase II / Phase III Interventional Respiratory Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nalbuphine hydrochloride injection, Hydromorphone hydrochloride injection.
Who it may be relevant to
Registry conditions: Respiratory Insufficiency. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug 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)
  • Drug Hydromorphone hydrochloride injection
    A maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h)

Primary outcome measures

  • The analgesic success rate [Time frame: Within 24 hours while receiving the study drug]
Secondary outcome measures (3)
  • The percentage of time with light sedation duration [Time frame: Within 24 hours while receiving the study drug]
  • The amout of propfol used [Time frame: Within 24 hours while receiving the study drug]
  • Successful extubation [Time frame: Within 24 hours while receiving the study drug]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Wuhan Union Hospital — Wuhan

Publications

  • Zhang Y, Yuan Y, Ren L, Jiang W, Sun S, Wang R, Li Z, Peng Q, Gong R, Yang X, Shang Y. Protocol for a multicenter, randomized, single-blind, non-inferiority trial comparing nalbuphine hydrochloride versus hydromorphone hydrochloride for analgesia in mechanically ventilated ICU patients. Front Pharmacol. 2026 Apr 28;17:1795531. doi: 10.3389/fphar.2026.1795531. eCollection 2026. PMID 42131816

Identifiers

NCT: NCT06785571 · 2023-0407

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗