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

NCT06785571 | Recruiting Phase 2

• 1 other identifier: 2023-0407
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• The analgesic success rate

  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

  Within 24 hours while receiving the study drug

Secondary Outcomes (3)

• The percentage of time with light sedation duration

  Within 24 hours while receiving the study drug

• The amout of propfol used

  Within 24 hours while receiving the study drug

• Successful extubation

  Within 24 hours while receiving the study drug

Other Outcomes (3)

• Cmax

  Within 24 hours while receiving the study drug

• The area under the plasma drug concentration-time curve

  Within 24 hours while receiving the study drug

• t1/2

  Within 24 hours while receiving the study drug

Study Arms (5)

lower loading dose of Nalbuphine hydrochloride for step 1

EXPERIMENTAL

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)

Drug: Nalbuphine hydrochloride injection

higher loading dose of Nalbuphine hydrochloride for step 1

EXPERIMENTAL

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)

Drug: Nalbuphine hydrochloride injection

Hydromorphone hydrochloride injection for step 1

ACTIVE COMPARATOR

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

Drug: Hydromorphone hydrochloride injection

The optimal loading of Nalbuphine hydrochloride injection for step 2

EXPERIMENTAL

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)

Drug: Nalbuphine hydrochloride injection

Hydromorphone hydrochloride injection for step 2

ACTIVE COMPARATOR

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

Drug: Hydromorphone hydrochloride injection

Interventions

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)

The optimal loading of Nalbuphine hydrochloride injection for step 2; higher loading dose of Nalbuphine hydrochloride for step 1; lower loading dose of Nalbuphine hydrochloride for step 1

Hydromorphone hydrochloride injection DRUG

A maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h)

Hydromorphone hydrochloride injection for step 1; Hydromorphone hydrochloride injection for step 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Other conditions deemed unsuitable to be included

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Yichang Humanwell Pharmaceutical Co., Ltd., China: collaborator

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Nalbuphine; Hydromorphone

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Morphine Derivatives

Central Study Contacts

you shang

CONTACT

02785351606; you_shanghust@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 21, 2025
• Study Start: August 30, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: January 21, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)