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NCT Number: 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

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.

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Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. The analgesic success rate

    Time frame: Within 24 hours while receiving the study drug

    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

Secondary outcomes

  1. The percentage of time with light sedation duration

    Time frame: Within 24 hours while receiving the study drug

    Light sedation duration is defined as subjects with CPOT ≤ 2 points and -2 points ≤ RASS ≤ 1

  2. The amout of propfol used

    Time frame: Within 24 hours while receiving the study drug

    The amout of propfol used

  3. Successful extubation

    Time frame: Within 24 hours while receiving the study drug

    Successful extubated without reintubation

Other outcomes

  1. Cmax

    Time frame: Within 24 hours while receiving the study drug

    peak plasma concentration

  2. The area under the plasma drug concentration-time curve

    Time frame: Within 24 hours while receiving the study drug

    The area under the plasma drug concentration-time curve (AUC)

  3. t1/2

    Time frame: Within 24 hours while receiving the study drug

    half-life

Study contacts

Contact information is provided by the study sponsor or research team.

you shang

CONTACT

[email protected]

02785351606

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Yichang Humanwell Pharmaceutical Co., Ltd., China

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 21, 2025
Registry last updated
Jan 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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