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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• The analgesic success rate [Срок оценки: Within 24 hours while receiving the study drug]

Вторичные конечные точки (3)

• The percentage of time with light sedation duration [Срок оценки: Within 24 hours while receiving the study drug]
• The amout of propfol used [Срок оценки: Within 24 hours while receiving the study drug]
• Successful extubation [Срок оценки: Within 24 hours while receiving the study drug]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Wuhan Union Hospital — Ухань

Публикации

• 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

Идентификаторы

NCT: NCT06785571 · 2023-0407

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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