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

Last updated: January 19, 2025
Sponsor: Wuhan Union Hospital, China
Overall Status: Active - Recruiting

Phase

2/3

Condition

Lung Injury

Respiratory Failure

Treatment

Hydromorphone hydrochloride injection

Nalbuphine hydrochloride injection

Clinical Study ID

NCT06785571
2023-0407
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ICU patients who are intubated are expected to require mechanical ventilation formore than 6h

  2. patients or their guardians have a full understanding of the purpose andsignificance of this trial, and voluntarily participate in this clinical trial andsign an informed consent form

Exclusion

Exclusion Criteria:

  1. Allergy or unsuitability to any composition of study drugs or propofol

  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 glomerularfiltration 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

Study Design

Total Participants: 204
Treatment Group(s): 2
Primary Treatment: Hydromorphone hydrochloride injection
Phase: 2/3
Study Start date:
August 30, 2023
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Wuhan Union Hospital

    Wuhan, Hubei 430022
    China

    Active - Recruiting

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